Date | Title | Description |
18.09.2024 | Biosyngen's first-in-class CAR-T asset targeting solid tumors has entered pivotal phase II trial, Phase I trial data debut at ESMO 2024 Annual Congress | BARCELONA, Spain, Sept. 18, 2024 /PRNewswire/ -- The highly anticipated 2024 European Society for Medical Oncology (ESMO) Annual Congress has taken place in Barcelona, Spain. As one of the most influential annual gatherings in oncology, thi... |
18.09.2024 | Система обнаружения апноэ во сне Apple Watch получила одобрение FDA | Недавно Управление по контролю за продуктами и лекарствами США опубликовало одобрение на использование функции обнаружения апноэ во сне на часах Apple Watch Series 9, Series 10 и Watch Ultra 2, сообщает TechCrunch. «Зеленый свет» был дан за... |
17.09.2024 | Pairwise: Cultivating the Future of Agriculture with Gene Editing | In the heart of Durham, North Carolina, a revolution is brewing. Pairwise, a technology company at the forefront of gene editing, has just secured $40 million in Series C funding. This latest round, led by Deerfield Management, pushes their... |
17.09.2024 | FDA approves ribociclib with an aromatase inhibitor and ribociclib and letrozole co-pack for early high-risk breast cancer | FDA approves Kisqali with an aromatase inhibitor and Kisqali Femara Co-Pack for early high-risk breast cancer On September 17, 2024, the Food and Drug Administration approved ribociclib (Kisqali, Novartis Pharmaceuticals Corporation) with a... |
17.09.2024 | Pairwise raises $40m series C, forms JV with Corteva to accelerate gene editing on row crops | Pairwise, a startup pioneering gene editing in plants, has closed a $40m series C funding round and formed a five-year joint venture collaboration with agtech giant Corteva to advance the tech to increase climate resilience in corn and soy.... |
17.09.2024 | Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation - 11/07/2024 | On This Page
Date: November 7, 2024 Time: 1:00 PM - 2:30 PM ET
Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT (Hosted by CDER SBIA)
This webinar aims to inform stakeholders, particularly those who design, implement ... |
17.09.2024 | FDA Roundup: September 17, 2024 | For Immediate Release: September 17, 2024
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
Today, the FDA issued a draft guidance, “Integrating Randomized Controlled Trials for... |
17.09.2024 | FDA approves Kisqali with an aromatase inhibitor and Kisqali Femara Co-Pack for early high-risk breast cancer | On September 17, 2024, the Food and Drug Administration approved ribociclib (Kisqali, Novartis Pharmaceuticals Corporation) with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epiderma... |
16.09.2024 | CBER-Regulated Products with Supporting Documents | A None Aptima HIV-1 Quant Dx Assay Hologic, Inc.
None Adenovirus Type 4 and Type 7 Vaccine, Live, Oral Barr Labs, Inc.
ADAMTS13, recombinant-krhn ADZYNMA Takeda Pharmaceuticals U.S.A., Inc.
afamitresgene autoleucel TECELRA Adaptimmune LLC
A... |
16.09.2024 | Infusion Pump Administration Set Recall: Fresenius Kabi USA Removes Certain Ivenix Large Volume Pump Primary Administration Sets | This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product
Product N... |
16.09.2024 | «Оземпик» превратили в гидрогель.Его не надо колоть еженедельно, а достаточно нанести раз в месяц | Исследователи из Франции разработали систему введения семаглутида один раз в месяц на основе гидрогеля, что значительно упрощает лечение диабета и контроль веса. Она будет представлена на ежегодном собрании Европейской ассоциации по изучени... |
16.09.2024 | Sleep apnea detection is now available for these two Apple Watches | Last week, during the “It’s Glowtime” event, Apple announced that sleep apnea tracking would arrive on the Apple Watch as soon as it received Food and Drug Administration (FDA) approval. That approval has now arrived, and as such, the sleep... |
16.09.2024 | 3D Systems receives FDA approval for new 3D printed surgical guides | US-based 3D printer manufacturer 3D Systems has received 510(k) clearance from the Food and Drug Administration (FDA) for its 3D printed Total Ankle pre-surgical planning and instrument set.
The new offering is personalized to meet specific... |
16.09.2024 | Product Safety Compliance for Medical Devices According to the IEC 60601 Series, Upcoming Webinar Hosted by Xtalks | www.element.com/connected-technologies
In this free webinar, learn about product safety requirements for medical devices. Attendees will learn what essential performance is and how to identify it. The featured speaker will discuss key test ... |
16.09.2024 | July - September 2019 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) | Cisplatin
Generic products containing cisplatin Aortic thrombosis FDA has determined that the last approved labeling is adequate, and that no further regulatory action is needed at this time.
Cyclin-Dependent Kinase 4 and 6 (CDK 4 and CDK 6... |
16.09.2024 | Current Good Manufacturing Practice Declarations | Issuing Current Good Manufacturing Practice Declarations
FDA issues letters, called current good manufacturing practice (CGMP) declarations, to foreign regulators that convey CGMP compliance status of establishments FDA has inspected.
Facil... |
16.09.2024 | Inflammatix: Molecular Diagnostics Company Closes $57 Million In Funding (Series E) | Molecular diagnostics company Inflammatix announced it raised $57 million in Series E funding led by Khosla Ventures and Think.Health. This funding round will support regulatory filing and early commercialization of the company’s lead produ... |
16.09.2024 | Electronic Certificates of Pharmaceutical Product | Facilities exporting drugs are often asked by foreign customers or foreign governments to provide documentation of the facility’s compliance with FDA requirements.
FDA issues electronic certificate of pharmaceutical product (eCPP) for appro... |
16.09.2024 | January - March 2019 | Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS) | Product Name: Trade (Active Ingredient) or Product Class
Potential Signal of a Serious Risk / New Safety Information
Additional Information
(as of August 5, 2024)
Afinitor (everolimus)
Afinitor Disperz (everolimus)
Nexavar (sorafenib tosyla... |
15.09.2024 | USFDA cites manufacturing lapses at Zydus Lifesciences' Jarod plant | The US health regulator has pulled up Zydus Lifesciences for manufacturing lapses at its Gujarat-based plant.
In a warning letter to company's Managing Director Sharvil Patel, the US Food and Drug Administration (USFDA) noted that the drug ... |
15.09.2024 | SAGE Investors Have Opportunity to Lead Sage Therapeutics, Inc. Securities Fraud Lawsuit | NEW YORK, Sept. 15, 2024 /PRNewswire/ -- Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Sage Therapeutics, Inc. (NASDAQ: SAGE) between April 12, 2021 and July 23, 2024, both dates inclusive (the "... |
14.09.2024 | Ford патентует голографических собак, Tesla — зарядный коврик, а Google — изогнутые волноводы. Дайджест новостей | В агротехе пытаются избавиться от пестицидов, Apple теперь может продавать слуховые аппараты, а в России заживляют раны и контролируют ВИЧ. Главные новости в сфере интеллектуальной собственности за неделю в нашем дайджесте.У Sony в пять раз... |
14.09.2024 | Breakthrough Therapy designation for Sanbexin sublingual tablets granted by the United States Food and Drug Administration | NANJING, China, Sept. 14, 2024 /PRNewswire/ -- On September 2, 2024, Simcere Pharmaceuticals Group Ltd. (2096.HK) announced that Sanbexin Sublingual Tablets (Edaravone and Dexborneol sublingual tablets), an innovative drug for stroke, has b... |
14.09.2024 | Новый анализ крови может выявить риск сердечно-сосудистых заболеваний за несколько лет до симптомов | Новое исследование показывает, что анализ крови на содержание определенных жиров и маркеров воспаления позволяет предвидеть сердечно-сосудистые заболевания (ССЗ) у женщин за несколько лет до появления симптомов, что является значительным ша... |
13.09.2024 | Bridging the Gap: Innovations in Kidney Care and Healthcare Interoperability | In the world of healthcare, innovation is the lifeblood that keeps patients thriving. Recently, two significant developments have emerged, shedding light on the future of kidney care and the pressing need for interoperability in healthcare ... |
13.09.2024 | A New Dawn in Immunotherapy and Global Raw Materials: The Rise of ALYGLO and Bloomage | In the world of healthcare and biotechnology, two recent developments stand out like beacons of hope. GC Biopharma has launched ALYGLO, a new immune globulin therapy, while Bloomage has reported a significant shift in its market dynamics. B... |
13.09.2024 | Apple’s AirPods Pro: A Game-Changer in Hearing Aid Technology | In a world where technology evolves at lightning speed, Apple has once again made waves. The U.S. Food and Drug Administration (FDA) has given the green light for AirPods Pro to double as hearing aids. This is not just a minor tweak; it’s a... |
13.09.2024 | New Frontiers in Bladder Cancer Treatment and Alzheimer’s Research: A Dual Perspective | In the realm of medical science, breakthroughs often come with the force of a tidal wave. Two recent studies highlight this dynamic, one focusing on bladder cancer and the other on Alzheimer’s disease. Each represents a significant leap for... |
13.09.2024 | The New Wave of Healthcare Innovation: Leaders Shaping the Future | The healthcare landscape is evolving. Two recent appointments highlight this shift. Closed Loop Medicine and Highlander Health are at the forefront, steering the ship toward a more personalized and efficient future. Closed Loop Medicine, a ... |
13.09.2024 | Apple получила разрешение на использование AirPods Pro 2 в качестве слухового аппарата | Управление по контролю качества пищевых продуктов и лекарственных средств США (FDA) одобрило использование AirPods Pro 2 в качестве слухового аппарата. Регулятор начал выдавать разрешения на применение безрецептурных слуховых аппаратов с 20... |
13.09.2024 | UPDATED AGENDA INFORMATION: September 13, 2024: Meeting of the Gastrointestinal Drugs Advisory Committee Meeting Announcement - 09/13/2024 | On This Page
Date: September 13, 2024 Time: 8:30 AM - 5:00 PM ET What is an advisory committee?
Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound... |
12.09.2024 | Ractigen's RAG-17: A Beacon of Hope in ALS Treatment | In the world of medicine, breakthroughs often emerge from the shadows of despair. Ractigen Therapeutics is shining a light on amyotrophic lateral sclerosis (ALS) with its latest development, RAG-17. This small interfering RNA (siRNA) therap... |
12.09.2024 | Apple Releases AirPods Pro 2 To Serve As Hearing Aids | Share
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Apple has announced that its AirPods Pro 2 headphones will soon function as FDA-cleared hearing aids through a software update, potentially benefiting 30 million Americans.
TakeAway Points: Apple’s AirPods Pro ... |
12.09.2024 | FDA authorizes first OTC hearing aid software to be used in Apple's AirPods Pro | Previous
FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
FILE PHOTO: The fourth generation of AirPods is showcased as ... |
12.09.2024 | FDA Authorizes First Over-the-Counter Hearing Aid Software | For Immediate Release: September 12, 2024
Today, the U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple A... |
12.09.2024 | Health | Study finds toxic metals in tampons: FDA launches investigation | One of the key questions will be determining how much, if any, of the metals leach out of the tampons and are absorbed by the body.
The recent study, published in the journal Environment International, evaluated levels of 16 metals in tampo... |
12.09.2024 | New Report: U.S. Rates of Obesity Among Adults at Epidemic Levels | Obesity Rates are Predominantly Highest in Communities Experiencing Barriers to Healthy Eating and Those with Few Opportunities for Physical Activity
WASHINGTON, Sept. 12, 2024 /PRNewswire/ -- Obesity rates for U.S. adults were at or higher... |
12.09.2024 | Join FDA for the First National Hispanic/Latino Family Cancer Awareness Week, Sept. 20-26 | Image
By: Luckson Mathieu, MD, Senior Clinical Reviewer, DO2, OND; Donna Rivera, PharmD, Associate Director for Pharmacoepidemiology, Oncology Center of Excellence (OCE), and Rea Blakey, Associate Director for External Outreach and Engageme... |
11.09.2024 | Bloomage 2024 Mid-Year Report: International Raw Materials Sales Surpass Domestic Chinese Market's for the First Time | PARSIPPANY, N.J., Sept. 11, 2024 /PRNewswire/ -- Bloomage, a global leader in hyaluronic acid and other bioactive substance innovations, showcased robust growth in its raw materials business in its newly released 2024 mid-year financial rep... |
11.09.2024 | Болезнь Альцгеймера может оказаться аутоиммунным заболеванием | Поиски лекарства от болезни Альцгеймера становятся все более конкурентными и спорными, и в последние годы в этой области появилось несколько важных противоречий.
В июле 2022 года журнал Science сообщил, что ключевая научная работа 2006 года... |
11.09.2024 | FDA Rare Disease Innovation Hub | Fundamental to the mission of the U.S. Food and Drug Administration is to engage patients and caregivers – to understand their unique perspectives and experiences and keep these front of mind as we review medical products for rare disease p... |
10.09.2024 | Revolutionizing Healthcare: The Dawn of AI and Innovative Sterilization Solutions | In the fast-paced world of healthcare, innovation is the lifeblood that keeps the industry thriving. Two recent breakthroughs illustrate this trend: the FDA clearance of the CADDIE™ AI endoscopy system and the EO Chex™ ethylene oxide indica... |
10.09.2024 | Ractigen Announces Positive Clinical Data for RAG-17 in ALS-SOD1 Treatment from Investigator-Initiated Trial | NANTONG, China and SUZHOU, China, Sept. 10, 2024 /PRNewswire/ -- Ractigen Therapeutics, a clinical-stage pharmaceutical company dedicated to developing innovative therapies, today announced promising clinical data from an Investigator-Initi... |
10.09.2024 | Ractigen Announces Positive Clinical Data for RAG-17 in ALS-SOD1 Treatment from Investigator-Initiated Trial | NANTONG, China and SUZHOU, China, Sept. 10, 2024 /PRNewswire/ -- Ractigen Therapeutics, a clinical-stage pharmaceutical company dedicated to developing innovative therapies, today announced promising clinical data from an Investigator-Initi... |
10.09.2024 | Former FDA/Verily’s Amy Abernethy Launches Highlander Health | Amy Abernethy, M.D., Ph.D., Co-Founder & Brad Hirsch, M.D Co-Founder at Highlander Health
What You Should Know:
– Industry veterans Amy Abernethy, M.D., Ph.D., and Brad Hirsch, M.D., have co-founded Highlander Health, a new company dedi... |
10.09.2024 | FDA отозвала татуировочные чернила, которые содержат потенциально инфекционные микроорганизмы | Компания Sierra Stain отозвала три вида татуировочных чернил марки Bloodline после обнаружения высоких концентраций бактерий, что может угрожать здоровью потребителей. FDA призвала прекратить использование этих продуктов и обратиться в Упра... |
10.09.2024 | The Annual PDA/FDA Joint Regulatory Conference Draws Record Audience | 2024 PDA/FDA Joint Regulatory Conference
PDA's thirty-third Joint Regulatory Conference with the U.S. FDA breaks previous attendance record.
BETHESDA, Md., Sept. 9, 2024 /PRNewswire-PRWeb/ -- PDA is pleased to announce that they have set a ... |
10.09.2024 | VasQ™ Extravascular Support Granted Transitional Pass-Through (TPT) Payment | Laminate Medical Technologies Thanks Kidney Patients for Advocacy
NEW YORK, Sept. 10, 2024 /PRNewswire/ -- Laminate Medical Technologies today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) granted their VasQ™ ex... |
10.09.2024 | ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA - 09/10/2024 | On This Page
Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT (Hosted by CDER SBIA)
FDA revised the final guidance for industry entitled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA... |
09.09.2024 | The FDA's Evolving Role in Public Health and Innovative Research | The U.S. Food and Drug Administration (FDA) is a guardian of public health. It ensures the safety and efficacy of drugs, food, and medical devices. Recently, the agency has been busy, addressing a range of issues from medical device sterili... |
09.09.2024 | The Ripple Effect of FDA's New Lab Test Rule: A Looming Crisis for Underserved Communities | The recent ruling by the Food and Drug Administration (FDA) regarding laboratory developed tests (LDTs) has sent shockwaves through the healthcare landscape. The Association for Diagnostics & Laboratory Medicine (ADLM) has raised alarms... |
09.09.2024 | GC Biopharma Launches ALYGLO™ (Immune Globulin Intravenous, Human-stwk) 10% Liquid for Adults, an Immune Globulin for the Treatment of Primary Humoral Immunodeficiency (PI) - Now Available in the US M... | TEANECK, N.J., Sept. 9, 2024 /PRNewswire/ -- GC Biopharma USA, Inc. announced the launch and distribution of its immunoglobulin (IG) product ALYGLO (immune globulin intravenous, human-stwk), the company's first 10% intravenous immunoglobuli... |
09.09.2024 | Propper Manufacturing Company Announces FDA Clearance of New EO Chex™ Ethylene Oxide Indicator Tape | EO Chex™ FDA Cleared Ethylene Oxide Indicator Tape is available for purchase now!
EO Chex™ Tape the only FDA-cleared EO tape available for purchase.
LONG ISLAND CITY, N.Y., Sept. 9, 2024 /PRNewswire-PRWeb/ -- Propper Manufacturing Company i... |
09.09.2024 | Breakthrough Therapy BAY 2927088 Demonstrates 'Rapid, Substantial and Durable Responses' in Patients with HER2-Mutant NSCLC | Xiuning Le, M.D., Ph.D., The University of Texas MD Anderson Cancer Center, Houston
Treatment with BAY 2927088 led to rapid, substantial, and durable responses in patients with heavily pretreated HER2-mutant non-small cell lung cancer (NSCL... |
09.09.2024 | Sugar replacement: Bonumose secures preliminary victory over ‘arbitrary and capricious’ FDA on tagatose labeling | Virginia-based startup Bonumose has secured a preliminary victory in its battle with the US Food and Drug Administration (FDA) over the labeling of tagatose, a low-glycemic, tooth-friendly rare sugar with 92% of the sweetness of regular sug... |
06.09.2024 | FDA Roundup: September 6, 2024 | SILVER SPRING, Md., Sept. 6, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
On Sept. 11 from 1-2 p.m. ET, the FDA will host a virtual Medical Device Ster... |
06.09.2024 | Mice Skin Becomes Transparent Using Common Food Dye, Is This Also Possible to Human Skin? | By Joseph Henry
Published Sep 6, 2024 8:33AM EDT
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Transparent bodies of animals are seldom seen in the wild. There are glassfrogs and gho... |
05.09.2024 | The Future of Pet Food and Seafood: Innovations Shaping Sustainable Choices | The world of pet food and seafood is evolving. Two industries, both crucial to our diets and lifestyles, are now facing unprecedented challenges and opportunities. As consumers become more conscious of sustainability, companies are stepping... |
05.09.2024 | First Cloud-Based AI Endoscopy System for Colonoscopy Receives FDA Clearance | Leveraging the power of the cloud and AI to improve clinical outcomes
CENTER VALLEY, Pa., Sept. 5, 2024 /PRNewswire/ -- Odin Medical Ltd., an Olympus Corporation company, has received U.S. Food and Drug Administration (FDA) 510(k) clearance... |
05.09.2024 | DOH recommends Respiratory Virus Immunizations | Posted on Sep 4, 2024 in COVID-19, Newsroom
DOH RECOMMENDS RESPIRATORY VIRUS IMMUNIZATIONS
HONOLULU — The Hawai‘i Department of Health (DOH) recommends the recently updated 2024-2025 flu and COVID-19 vaccines for all persons 6 months of age... |
05.09.2024 | Association for Diagnostics & Laboratory Medicine (formerly AACC) survey finds that FDA's final laboratory developed tests rule will hinder patient care for underserved communities | WASHINGTON, Sept. 5, 2024 /PRNewswire/ -- Today, the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) released the latest results from an ongoing survey that ADLM has been conducting to determine how the Food and ... |
05.09.2024 | Nearly 2,000 drug plants overdue for FDA checks after COVID delays, analysis finds | - |
04.09.2024 | Navigating the Food Landscape: Challenges and Innovations in Traceability and Consumer Behavior | The food industry is a complex web. It’s a dance of supply and demand, regulations and consumer preferences. As we step into 2024, two key themes emerge: traceability and consumer behavior. Both are reshaping how we think about food, sustai... |
04.09.2024 | August's top 10 pet food headlines | 10. Mars Petcare, Big Idea Ventures launch sustainable pet food program (August 26)
The Next Generation Pet Food Program aims to drive innovation in pet food and engage with the startup ecosystem to develop more sustainable solutions.
9. Mu... |
03.09.2024 | The Political Landscape: A Tale of Two Campaigns | The 2024 presidential race is heating up. Two candidates, Kamala Harris and Donald Trump, are vying for the highest office in the land. Their strategies reveal much about their visions for America. Harris, the Democratic nominee, and Trump,... |
03.09.2024 | Ensuring Safe Drinking Water: A Closer Look at the Hidden Risks in Bottled Water | JAKARTA, Indonesia, Sept. 3, 2024 /PRNewswire/ -- NGO Sirkadian, focusing on public health and environmental advocacy, recently discussed with Prof. Yuni K. Krisnandi, M.Sc., Ph.D., an inorganic chemistry expert and a member of the Royal So... |
03.09.2024 | Skyline Therapeutics' Novel Gene Therapy SKG1108 Receives FDA Orphan Drug Designation for Retinitis Pigmentosa | BOSTON and SHANGHAI, Sept. 3, 2024 /PRNewswire/ -- Skyline Therapeutics, an innovation-driven gene therapy company committed to developing unique and novel solutions for rare and severe diseases, announced that the US Food and Drug Administ... |
03.09.2024 | The traceability trifecta: Revolutionizing food systems for profit, planet and people | Evolving pressures in the food industry are making it a challenge to achieve sustainability and meet the requirements of regulations, while also maintaining profitability. It's clear, however, that one of the most effective paths is through... |
02.09.2024 | Health | CDC sees link between overdoses, other mental health disorders | She said public health professionals can also amp up harm reduction services, like naloxone distribution to reverse opioid overdose. The FDA in 2023 approved the first over-the-counter naloxone products. They are now available in all 50 sta... |
31.08.2024 | FDA Authorizes Updated Novavax COVID-19 Vaccine to Better Protect Against Currently Circulating Variants | For Immediate Release: August 30, 2024
Today, the U.S. Food and Drug Administration granted emergency use authorization (EUA) for an updated version of the Novavax COVID-19 vaccine that more closely targets currently circulating variants to... |
30.08.2024 | FDA Authorizes Updated Novavax COVID-19 Vaccine to Better Protect Against Currently Circulating Variants | SILVER SPRING, Md., Aug. 30, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration granted emergency use authorization (EUA) for an updated version of the Novavax COVID-19 vaccine that more closely targets currently circulating ... |
30.08.2024 | December 4, 2024: Meeting of the Pharmacy Compounding Advisory Committee - 12/04/2024 | On This Page
Date: December 4, 2024 Time: 8:00 AM - 5:00 PM ET
Location:
Event Location
FDA Headquarters
FDA headquarters in White Oak, MD
10903 New Hampshire Ave
Silver Spring, MD 20903
United States
What is an advisory committee?
Advisory... |
30.08.2024 | Medical products for rare diseases and conditions | Rare diseases affect patients and their families. Over 7,000 rare diseases affect more than 30 million people in the United States. Many rare conditions are life threatening and most do not have treatments.
The FDA works to enhance to the a... |
30.08.2024 | October 29, 2024: Meeting of the Pharmacy Compounding Advisory Committee - 10/29/2024 | On This Page
Date: October 29, 2024 Time: 8:00 AM - 5:00 PM ET
Location:
Event Location
FDA Headquarters
FDA headquarters in White Oak, MD
10903 New Hampshire Ave
Silver Spring, MD 20903
United States
What is an advisory committee?
Advisory... |
30.08.2024 | FDA Authorizes Updated Novavax COVID-19 Vaccine to Better Protect Against Currently Circulating Variants | For Immediate Release: August 30, 2024
Today, the U.S. Food and Drug Administration granted emergency use authorization (EUA) for an updated version of the Novavax COVID-19 vaccine that more closely targets currently circulating variants to... |
30.08.2024 | Asli Fine Foods . Recalls Asli Cinnamon Powder 7 oz Because of Possible Health Risk | COMPANY ANNOUNCEMENT
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product... |
29.08.2024 | Mabwell's Bold Step: A New Hope for Urothelial Carcinoma | In the bustling heart of Shanghai, Mabwell is making waves. The biopharmaceutical company recently received the green light from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to kick off a Phase... |
29.08.2024 | FDA Issues Final Rule Increasing the Minimum Age for Certain Restrictions on Tobacco Sales | Tobacco Retailers Will Need to Verify Age for Anyone Under 30; Vending Machine Sales Will Be Restricted to 21+ Facilities
SILVER SPRING, Md., Aug. 29, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration announced a final rule ... |
29.08.2024 | Are shoppers’ concerns around food inflation starting to ease? | Listen to the article 3 min
This audio is auto-generated. Please let us know if you have feedback. Dive Brief:
Consumer concern about food affordability over the past year has declined, and the majority of shoppers continue to feel they hav... |
29.08.2024 | В чернилах для татуировок с Amazon нашли странные и редкие бактерии | Управление по контролю за продуктами и лекарствами США предупредило, что чернила для перманентного макияжа и татуировок, которые продаются на Amazon, содержат бактерии, которые могут вызывать воспалительные реакции, аллергию и инфекции.
На ... |
29.08.2024 | New Arizona Billboard Aims to Reduce Suicide by Increasing Akathisia Awareness | A new public health ad in Phoenix increases akathisia awareness
Darius Ghanat, advocate and akathisia survivor
Akathisia Awareness Saves Lives
Akathisia is a medication-induced disorder that can cause self harm, violence, and suicide
Tragic... |
28.08.2024 | The Eviction Dilemma: Balancing Tenant Rights and Landlord Concerns | Eviction records are like shadows. They linger long after the sun has set. For many tenants, these records can be a scarlet letter, marking them as unworthy in the eyes of future landlords. As states across the U.S. begin to seal eviction r... |
28.08.2024 | Inhalation Sciences AB (publ) releases Q2 Report 2024 | Inhalation Sciences AB (publ) releases Q2 Report 2024
Wed, Aug 28, 2024 08:30 CET Report this content
(Stockholm, Sweden, 28 August 2024) Inhalation Sciences AB announces that its Q2 Report for 2024 is now available on the company’s website... |
28.08.2024 | Jenscare, with innovative TTVR, releases 2024H1 interim results | BEIJING, Aug. 28, 2024 /PRNewswire/ -- Jenscare Scientific Co., Ltd. ("Jenscare" or the "Company") (HKEX: 9877), an innovative medical device company dedicated to interventional treatment for structural heart diseases wi... |
28.08.2024 | Telix Submits NDA for TLX101-CDx (Pixclara®) Brain Cancer Imaging Agent | MELBOURNE, Australia, Aug. 28, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces it has submitted a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) fo... |
27.08.2024 | Vigna Law Group: Más Malas Noticias para la Malla de Uretra Media Coloplast Altis: Dolor en la Ingle | Dr. Greg Vigna
Las mini-mallas no reducen el dolor en la ingle en comparación con las mallas mid-uretrales de longitud completa
El dispositivo Altis debería tener una bandera. La FDA aún no respalda la seguridad y eficacia de las mini malla... |
27.08.2024 | FDA Roundup: August 27, 2024 | For Immediate Release: August 27, 2024
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
On Monday, the FDA revised the Emergency Use Authorization for Pemgarda (pemivibart) to ... |
27.08.2024 | Founder and Chief Executive Officer of Injectable Stem Cell Product Manufacturer Pleads Guilty to Felony Distribution of Unapproved Drug | The founder and chief executive officer of a California-based company that marketed stem cell-based products linked to multiple hospitalizations pleaded guilty today to a felony violation of the Federal Food, Drug and Cosmetic Act.
John W. ... |
27.08.2024 | GenBio Inc, is Pleased to Announce the Filing of a Provisional Patent for its Identified Therapeutic Compound | GenBio Inc.
This marks a major milestone for GenBio Inc and its ongoing efforts to revolutionize the future of medicine.
The fundamental activity of medical science is to determine the ultimate causation of disease.”
— Wilfred Trotter
ALISO... |
27.08.2024 | FDA Roundup: August 27, 2024 | SILVER SPRING, Md., Aug. 27, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
On Monday, the FDA revised the Emergency Use Authorization for Pemgarda (pemi... |
27.08.2024 | ArkBio Presented at the 8th Annual IPF Summit and Announced Completion of Patient Enrollment for Phase 2 Clinical Trial of AK3280, a Next-Generation Drug for IPF Treatment | BEIJING, Aug. 27, 2024 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio"), a privately held, clinical-stage biopharmaceutical company today announced that Dr. Jim Wu, Chief Executive Officer of ArkBio, gave an ora... |
26.08.2024 | Mabwell Announces CDE Approval to Initiate Phase III Clinical Trial of 9MW2821 for Urothelial Carcinoma in Combination with PD-1 Inhibitor | SHANGHAI, Aug. 26, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its submission to the Center for Drug Evaluation (CDE) of the National Medical Products Administ... |
26.08.2024 | Mabwell Announces CDE Approval to Initiate Phase III Clinical Trial of 9MW2821 for Urothelial Carcinoma in Combination with PD-1 Inhibitor | SHANGHAI, Aug. 26, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its submission to the Center for Drug Evaluation (CDE) of the National Medical Products Administ... |
26.08.2024 | SIFI Receives European Commission Approval for AKANTIOR® | AKANTIOR® (polihexanide) is the first and only approved drug for the treatment of acanthamoeba keratitis
CATANIA, Italy, Aug. 26, 2024 /PRNewswire/ -- SIFI, a leading international ophthalmic company, today announced the European Commission... |
26.08.2024 | Opna Bio Doses First Patient in Phase 1 Study in Multiple Myeloma with OPN-6602, an EP300/CBP Bromodomain Inhibitor | Appoints Axel Bolte, MBA, MSc, to Board Director and Stephanie Oestreich, PhD, MPA, to Board Observer
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–August 26, 2024–
Opna Bio announced that it has dosed the first patient with OPN-6602, a poten... |
24.08.2024 | Sri Lakshmi Narasimhar Overseas LLC Issues an Allergy Alert on Undeclared Milk and Sesame Seeds in Bliss Tree Butter Snacks | COMPANY ANNOUNCEMENT
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product... |
24.08.2024 | Sierra Stain Recalls Tattoo Pigments Because of Possible Health Risk | COMPANY ANNOUNCEMENT
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product... |
23.08.2024 | Gutierrez Distributor Expands Recall of Ground Cinnamon Because of Possible Health Risk | COMPANY ANNOUNCEMENT
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product... |
23.08.2024 | Clot Removal Device Correction: Inari Medical Updates Use Instructions for ClotTriever XL Catheter due to Reports of Patient Injury and Death from Device Entrapment and Pulmonary Emboli | This recall involves updating instructions for using the ClotTriever XL, 30mm device, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. Affected Product
Product... |
23.08.2024 | FDA Roundup: August 23, 2024 | For Immediate Release: August 23, 2024
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
Today, the FDA issued a Small Entity Compliance Guide (SECG) to assist small entities, i... |