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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’)...

FDA Approves Penpulimab-kcqx for the Treatment of Advanced Nasopharyngeal Carcinoma

Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is excited to announce that the U.S. Food and Drug Administration (FDA) has approved its differentiated...

Estimated 7.2 Million Americans 65 Years and Older Have Alzheimer Dementia

An estimated 7.2 million Americans aged 65 years and older are living with Alzheimer dementia, and almost all adults feel it is important to diagnose the...

Prior Military Sexual Trauma Linked to Late-Life Suicide Attempt

Prior military sexual trauma (MST) is associated with late-life suicide attempt and death by suicide or overdose, according to a study published online...

Risk Factors for Alzheimer Disease Linked to Cognitive Function Before Midlife

Risk factors for Alzheimer disease are associated with cognitive function starting in the mid-20s, according to a study published in the May issue of The...

FDA Commissioner: No Major Reorganization, Just Smart Reforms

THURSDAY, May 1, 2025 — Dr. Marty Makary had just finished his last surgery at Johns Hopkins when he stepped into one of the most powerful roles...

Hypertensive Disorders of Pregnancy Adversely Affect Preemie Neurodevelopment

Maternal hypertensive disorders of pregnancy (HDP) are associated with adverse cognitive and language development in preterm infants at 2 years' corrected...

Study Finds Flourishing Doesn’t Always Mean Happiness

THURSDAY, May 1, 2025 — Flourishing is more than just being happy, and a new global study finds some countries are doing better than others when...

Top Science Journal Suspends Submissions Amid Budget Cuts

THURSDAY, May 1, 2025 — A well-known U.S. science journal focused on environmental health has stopped accepting new studies, raising alarms among...

Florida Moves to Ban Fluoride in Drinking Water

THURSDAY, May 1, 2025 — Florida state lawmakers have approved a bill to ban the addition of fluoride to public drinking water, a move that public...

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...

Boehringer’s New Zongertinib Data Demonstrates Durable and Clinically Meaningful Results in Patients with HER2 (ERBB2)-Mutant Advanced NSCLC

Ingelheim, Germany / Ridgefield, Conn., U.S., April 28, 2025 - Boehringer Ingelheim reported new and updated data from the Beamion LUNG-1 trial evaluating...

Johnson & Johnson’s TAR-200 Monotherapy Achieves High Disease-Free Survival of More Than 80 Percent in BCG-Unresponsive, High-Risk Papillary NMIBC

LAS VEGAS, April 26, 2025 – Johnson & Johnson (NYSE: JNJ) today announced first results from Cohort 4 of the Phase 2b SunRISe-1 study evaluating...

Where Have All The Insects Gone — And Why?

SATURDAY, April 26, 2025 — From beetles to moths, leafhoppers and butterflies, the world's insects are vanishing at a breakneck pace. Since 2017,...

Health Fixer Issues Voluntary Nationwide Recall of Male Ultra, Malextra, Electro Buzz, Ultra Armor and Male Ultra Pro

April 25, 2025 – Tempe, AZ, HEALTH FIXER is voluntarily recalling all lots of dietary supplements by the name of Male Ultra, Malextra, Electro Buzz,...

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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.

More FDA approvals

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...

More drugs in development