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Teva and Alvotech Announce FDA Approval of Interchangeability for Selarsdi (ustekinumab-aekn) with Stelara (ustekinumab)
PARSIPPANY, N.J. & REYKJAVÍK, Iceland, May 05, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries...
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’)...
FDA Approves SAPIEN 3 Platform for Asymptomatic Severe Aortic Stenosis
The U.S. Food and Drug Administration has approved the SAPIEN 3 platform, a transcatheter aortic valve replacement (TAVR) therapy, for patients with severe...
Power Outages Up Odds of Carbon Monoxide-Related ED Visits Among Children
Power outages increase the odds of carbon monoxide (CO)-related emergency department visits among children, according to a study published online May 5...
Emergency Department Visits for Asthma Increased During 2023 Wildfires
Increases in asthma-related emergency department visits were seen in Ontario in association with the 2023 wildfires, according to a study published online...
No-Touch Vein Harvesting Reduces Vein Graft Occlusion at Three Years
A no-touch vein harvesting technique reduces vein graft occlusion and improves patient outcomes at three-year follow-up among patients undergoing coronary...
Signatures of Disrupted Affective Sound Processing Identified in Tinnitus
For persons with sound sensitivity and tinnitus, accurate predictors of sensory disorder severity can be identified in pupil dilations and facial movements...
Man Bitten by Snakes 200 Times May Help Create New Antivenom
MONDAY, May 5, 2025 — Tim Friede has survived hundreds of snakebites — on purpose. For nearly two decades, he let some of the world’s...
Too Much Cinnamon May Interfere With Some Medications, Study Shows
MONDAY, May 5, 2025 — Consuming too much cinnamon might affect how your body absorbs some medications, new research shows. The study — published...
U.S. Sees Most Child Flu Deaths Since 2009
MONDAY, May 5, 2025 — More U.S. children have died from the flu this season than in any year since the 2009 swine flu pandemic, according to...
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...
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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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