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FDA Approves Imaavy (nipocalimab-aahu) for the Treatment of Generalized Myasthenia Gravis (gMG)
SPRING HOUSE, Pa., (April 30, 2025) – Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved...
FDA Approves Atzumi (dihydroergotamine) Nasal Powder for the Acute Treatment of Migraine
Satsuma Pharmaceuticals, Inc., a late-stage biopharmaceutical company dedicated to bringing novel treatments to people who suffer from migraine and other...
Rinvoq (upadacitinib) Receives U.S. FDA Approval for Giant Cell Arteritis (GCA)
AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved Rinvoq® (upadacitinib), 15 mg, once daily, for the...
FDA Approves Zevaskyn (prademagene zamikeracel) Gene Therapy for Patients with Recessive Dystrophic Epidermolysis Bullosa
Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the U.S. Food and Drug Administration (FDA) has approved Zevaskyn (pronounced as ‘ZEE-vah-skin’)...
New Molecular Test Could Double Leukemia Survival Rates
MONDAY, May 5, 2025 — Testing positive for leukemia actually saved the life of 51-year-old Jan Leahy, a business process owner from Wimbledon, England.Leahy...
Men Worse Off Than Women For 20 Top Health Problems Worldwide
MONDAY, May 5, 2025 — Men are much more likely than women to die early from the world’s 20 leading health problems, a new global study shows.Sickness...
New Drug Could Quell Uncontrolled High Blood Pressure
MONDAY, May 5, 2025 — An experimental drug might help people with uncontrolled high blood pressure, according to early clinical trial results.People...
Wildfire Smoke Flooded ERs With Asthma Cases
Asthma attacks caused emergency room surges during the 2023 Canadian wildfires, with smoke-filled air sending hundreds to the hospital daily, a new study...
Withdrawal of Flovent Led to Discontinuation of Inhaled Steroids for Children With Asthma
For children using fluticasone propionate, the withdrawal of the brand-name drug (Flovent) was associated with increased discontinuation of inhaled steroid...
Gluten-Free Diet for Celiac Disease Increases Arsenic Exposure in Children
Children with newly diagnosed celiac disease have increased arsenic exposure shortly after transitioning to a gluten-free diet, according to a study published...
Advanced Biological Age Linked to Increased Risk for Incident Dementia
Advanced biological age (BA) may be a risk factor for incident dementia, according to a study published online April 30 in Neurology. Yacong Bo, Ph.D.,...
Buprenorphine for Opioid Use Disorder in Pregnancy Can Improve Outcomes
For mothers with opioid use disorder (OUD), treatment with buprenorphine in pregnancy is associated with improved maternal and infant outcomes, according...
FDA Accepts Filing Application for Oral Semaglutide 25 mg, Which If Approved, Would Be The First Oral GLP-1 Treatment for Obesity
Today, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) submission for an investigational...
Do You Have Tinnitus? The Answer Might Be Written In Your Face
THURSDAY, May 1, 2025 — Subtle facial gestures linked to the body’s fight-or-flight response could be used to help diagnose people with tinnitus,...
HHS, NIH Launch Next-Generation Universal Vaccine Platform for Pandemic-Prone Viruses
The U.S. Department of Health and Human Services (HHS) and the National Institutes for Health (NIH) today announced the development of the next-generation,...
Monthly News Roundup - April 2025
FDA Approves FcRn Blocker Imaavy for the Treatment of Generalized Myasthenia Gravis The United States Food and Drug Administration (FDA) has approved...
Stealth BioTherapeutics Announces Delay in FDA Action Date for Barth Syndrome Application for Elamipretide
NEEDHAM, Mass., April 29, 2025 /PRNewswire/ — Stealth BioTherapeutics Inc. (the “Company” or “Stealth”), a clinical-stage...
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Latest FDA New Drug Approvals
- Imaavy Imaavy (nipocalimab-aahu) is a neonatal Fc receptor (FcRn) blocker used for the treatment of generalized myasthenia gravis.
- Atzumi Atzumi (dihydroergotamine mesylate) is a nasal powder formulation of the ergotamine derivative dihydroergotamine mesylate for the acute...
- Zevaskyn Zevaskyn (prademagene zamikeracel) is an autologous, cell sheet-based gene therapy for the treatment of recessive dystrophic epidermolysis bullosa.
Drugs in Development (Not yet approved)
- Yutrepia Yutrepia (treprostinil) is an inhaled dry powder formulation of treprostinil tentatively approved for the treatment of pulmonary arterial...
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