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| Apr 18, 2025 | Dupixent® (dupilumab) Approved in the U.S. as the First New Targeted Therapy in Over a Decade for Chronic Spontaneous Urticaria (CSU) | Approval based on Phase 3 trials demonstrating Dupixent significantly reduced itch and hives compared to placebo
In the U.S., there are more than 300,000 adults and adolescents aged 12 years and older living with CSU who remain symptomatic ... |
| Mar 8, 2025 | Dupixent® (dupilumab) Late-Breaking Positive Pivotal Data in Bullous Pemphigoid Presented at AAD | Five times more adults on Dupixent achieved sustained disease remission at 36 weeks compared to placebo; significant reductions were also seen in disease severity and itch
Dupixent also significantly reduced oral corticosteroid and rescue m... |
| Feb 18, 2025 | Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for the Targeted Treatment of Bullous Pemphigoid (BP) | If approved, Dupixent would be the first and only targeted medicine to treat BP in the U.S.; FDA decision expected by June 20, 2025
Priority Review granted based on positive pivotal results demonstrating significant improvements in sustaine... |
| Jan 9, 2025 | MotherToBaby Launches Unique Pregnancy Interactive Tool, FASD Podcast Series, Webinar to Highlight Birth Defects Awareness Month | Logo
Every January during Birth Defects Awareness Month, MotherToBaby, in partnership with health organizations across the country, aims to raise awareness about birth defects, their effects on the community and prevention efforts.
BRENTWOO... |
| Sep 27, 2024 | Dupixent® (dupilumab) Approved in China as the First-ever Biologic Medicine for Patients with Chronic Obstructive Pulmonary Disease (COPD) | Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based on two landmark Phase 3 trials showing Dupixent significantly reduced exacerbations, improved lung function and also improved health-r... |
| Sep 27, 2024 | Dupixent® (dupilumab) Approved in the U.S. as the First-ever Biologic Medicine for Patients with COPD | Dupixent is indicated for the approximately 300,000 adults in the U.S. with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype
Following recent approvals in the EU and China, the U.S. approval... |
| Sep 13, 2024 | Dupixent® (dupilumab) Approved in the U.S. as First and Only Treatment for Adolescents with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) | Following Priority Review, Dupixent is now available to patients as young as 12 years with inadequately controlled CRSwNP
Current treatment options leave many patients with uncontrolled disease and often result in the recurrence of nasal po... |
| Sep 11, 2024 | TREMFYA® (guselkumab) receives U.S. FDA approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson's leadership in inflammatory bowel disease | The first and only dual-acting interleukin-23 inhibitor approved in active ulcerative colitis, TREMFYA® showed highly statistically significant rates of endoscopic remission at one year in the pivotal QUASAR program1,2,3,4,5
TREMFYA® is now... |
| Sep 11, 2024 | Dupixent® (dupilumab) Is the First and Only Biologic to Achieve Significant Improvements in Disease Remission and Symptoms in Bullous Pemphigoid (BP) Positive Pivotal Trial | Trial met the primary and all key secondary endpoints in adults with moderate-to-severe disease; five times more patients achieved sustained disease remission with Dupixent than placebo
Dupixent is the first medicine to show significant ste... |
| Sep 11, 2024 | Dupixent® (dupilumab) Phase 3 Trial Confirms Significant Improvements in Itch and Hives for Patients with Chronic Spontaneous Urticaria (CSU) | Confirming the results of Study A, this second pivotal trial in biologic-naïve patients met primary and key secondary endpoints, showing treatment with Dupixent resulted in a nearly 50% reduction in itch and urticaria activity scores compar... |
| Aug 26, 2024 | Latest Dupixent® (dupilumab) and Itepekimab Data at ERS Highlight Scientific Innovation and Leadership in Respiratory Diseases | 20 abstracts, including 4 oral presentations, offer new treatment insights for chronic obstructive pulmonary disease (COPD), asthma and chronic rhinosinusitis with nasal polyps (CRSwNP)
Data from landmark Phase 3 trials for Dupixent in COPD... |
| Jul 3, 2024 | Dupixent® (dupilumab) Approved in the European Union as the First-ever Targeted Therapy for Patients with COPD | First-in-world approval of Dupixent for adults with uncontrolled COPD with raised blood eosinophils based on two landmark Phase 3 trials showing Dupixent significantly reduced exacerbations, improved lung function and also improved health-r... |
| Jun 26, 2024 | Dupixent® (dupilumab) Positive Phase 3 Data in Children 1 to 11 Years of Age with Eosinophilic Esophagitis Published in the New England Journal of Medicine | Majority of patients in this age group with eosinophilic esophagitis (EoE) receiving Dupixent achieved histologic remission, with improvements sustained up to one year
Dupixent is the first and only treatment indicated for EoE in the U.S. f... |
| May 16, 2024 | MotherToBaby Partners with National Hotline to Further Support Maternal Mental Health | MTB NMMHH logos
The National Maternal Mental Health Hotline Provides 24/7 Support Before, During, and After Pregnancy
BRENTWOOD, Tenn., May 16, 2024 /PRNewswire-PRWeb/ -- MotherToBaby, a no-cost service of the non-profit Organization of Ter... |
| Jan 3, 2024 | Being a chronically ill young adult is hard enough. Finding information about my fertility is even harder | I recently turned 25. I should be taking risks, jet-setting with other Barbies, and flouncing around in tiny tops. Instead, this chronically ill Barbie spent her first four days of 25 in a scene from “Oppenheimer.”
On my birthday, I spent n... |
| Oct 4, 2023 | MotherToBaby Secures Vital Funding to Empower Expectant Parents and Address Birth Defects | Logo
MotherToBaby is the Leading National Resource on Exposures during Pregnancy and Breastfeeding
BRENTWOOD, Tenn., Oct. 4, 2023 /PRNewswire-PRWeb/ -- The non-profit Organization of Teratology Information Specialists (OTIS), which provides... |
| May 21, 2023 | Dupixent® (dupilumab) Late-breaking Phase 3 COPD Results Presented at ATS and Simultaneously Published in the New England Journal of Medicine | /EIN News/ -- Dupixent is the first and only investigational biologic for COPD that has demonstrated a significant reduction in moderate or severe acute exacerbations by 30% compared to placebo
Dupixent is the first and only investigational... |
| Mar 21, 2023 | Dupixent® (dupilumab) Approved by European Commission as First and Only Targeted Medicine for Children as Young as Six Months Old with Severe Atopic Dermatitis | /EIN News/ -- Approximately seven times as many patients aged 6 months to 5 years with severe atopic dermatitis treated with Dupixent experienced clear or almost clear skin and reduced overall disease severity compared to placebo
Patients t... |
| Mar 18, 2023 | Dupixent® (dupilumab) Late-Breaking Data at AAD Show Significant Improvements in Signs and Symptoms of Moderate-to-severe Atopic Hand and Foot Dermatitis | /EIN News/ -- More than twice as many patients on Dupixent achieved clear or almost clear skin compared to placebo at 16 weeks
Nearly four times as many patients on Dupixent saw a clinically meaningful reduction of itch, with improvements s... |
| Feb 8, 2023 | Latest Information about Medication Safety in Breastmilk Now Easily Accessible via New LactRx App | LactRx Logo The LactRx app expands ease of access to this critical information for providers and the public worldwide.
BRENTWOOD, Tenn. (PRWEB) February 08, 2023
The non-profit Organization of Teratology Information Specialists (OTIS), thro... |
| Feb 1, 2023 | MotherToBaby Launches First Lupus in Pregnancy Research Study | "Lupus can raise the risk of pregnancy complications, so it’s important for both the mom and her developing baby that this condition be well-managed during pregnancy." - Christina Chambers, PhD, MPH
SAN DIEGO (PRWEB) February 01, ... |
| Sep 21, 2022 | MotherToBaby Bilingual Fact Sheets Now Included in the Prestigious National Library of Medicine | MotherToBaby Fact Sheets Now Included in the National Library of Medicine This is just one more way we can ensure pregnant people and healthcare providers can have access to reliable, up-to-date, research-based information so they can make ... |
| Jun 25, 2022 | Researchers Continue Study of COVID-19 Vaccinations in Pregnant People | This study will provide robust safety and effectiveness information regarding COVID-19 vaccinations during pregnancy that will allow pregnant people and their caregivers to make the most informed benefit-risk decisions.
MILWAUKEE (PRWEB) Ju... |
| Feb 1, 2022 | Regeneron Pharmaceuticals, Inc. - CHMP RECOMMENDS APPROVAL OF DUPIXENT (DUPILUMAB) FOR CHILDREN AGED 6 TO 11 YEARS WITH SEVERE ASTHMA WITH TYPE 2 INFLAMMATION | Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending to extend the approval of Dupixent (... |
| Dec 15, 2021 | Teratogen Experts Speak Out Against Misleading Study That Discourages Paracetamol Use in Pregnancy | MotherToBaby is a service of the Organization of Teratology Information Specialists These studies suffer from serious methodological problems.
BRENTWOOD, Tenn. (PRWEB) December 15, 2021
The non-profit Organization of Teratology Information ... |
| Dec 9, 2021 | New England Journal of Medicine Publishes Positive Phase 3 Dupixent® (dupilumab) Results in Children with Moderate-to-severe Asthma | TARRYTOWN, N.Y. and PARIS, Dec. 8, 2021 /PRNewswire/ --
Dupixent significantly reduced severe asthma attacks and improved lung function and asthma control in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma
Published ... |
| Dec 8, 2021 | New England Journal of Medicine Publishes Positive Phase 3 Dupixent® (dupilumab) Results in Children with Moderate-to-severe Asthma | TARRYTOWN, N.Y. and PARIS, Dec. 8, 2021 /PRNewswire/ --
Dupixent significantly reduced severe asthma attacks and improved lung function and asthma control in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma
Published ... |
| Oct 29, 2021 | MotherToBaby to Share Pregnancy, Breastfeeding Resources on World Psoriasis Day | The goal of our study is to gather information from pregnant people with psoriatic disease so we can better understand whether or not medications they are already taking may affect their pregnancy or their developing baby.
LA JOLLA, Calif. ... |
| Oct 21, 2021 | Regeneron Pharmaceuticals : FDA Expands Approval of Dupixent® (dupilumab) to Include Children Aged 6 to 11 Years with Moderate-to-severe Asthma | TARRYTOWN, N.Y. and PARIS, Oct. 20, 2021 /PRNewswire/ --
Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial, supporting potential as a best-in-class option
Only biolo... |
| Oct 20, 2021 | FDA Expands Approval of Dupixent® (dupilumab) to Include Children Aged 6 to 11 Years with Moderate-to-severe Asthma | TARRYTOWN, N.Y. and PARIS, Oct. 20, 2021 /PRNewswire/ --
Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial, supporting potential as a best-in-class option
Only biolo... |
| Jul 27, 2021 | Free Webinar to Address Effects of Prenatal Exposures on Development & Behavior | Free Prenatal Exposures Webinar-Advance Registration Required
ATLANTA (PRWEB) July 27, 2021
In collaboration with the National Society of Genetic Counselors, MotherToBaby, a non-profit service of the Organization of Teratology Information S... |
| Jun 29, 2021 | Regeneron Pharmaceuticals : - DUPIXENT (DUPILUMAB) SMPC UPDATED WITH LONG-TERM DATA REINFORCING WELL-ESTABLISHED SAFETY PROFILE IN ADULTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS | TARRYTOWN, N.Y. and PARIS - Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced that the European Medicines Agency will update the Dupixent (dupilumab) summary of product characteristics (SmPC) adding long-term safety result... |
| Apr 26, 2021 | AMGEN INC.
Amgen : OTEZLA (apremilast) Significantly Improved Measures Of Disease Severity In Adults With Mild-To-Moderate Plaque Psoriasis | THOUSAND OAKS, Calif. - Amgen (NASDAQ:AMGN) today announced Otezla (apremilast) improved measures of disease severity in adults with mild-to-moderate plaque psoriasis regardless of their Body Surface Area (BSA) affected by the disease, acco... |
| Apr 26, 2021 | Amgen : OTEZLA (apremilast) Significantly Improved Measures Of Disease Severity In Adults With Mild-To-Moderate Plaque Psoriasis | THOUSAND OAKS, Calif. - Amgen (NASDAQ:AMGN) today announced Otezla (apremilast) improved measures of disease severity in adults with mild-to-moderate plaque psoriasis regardless of their Body Surface Area (BSA) affected by the disease, acco... |
