Solid Biosciences Licenses AAV-SLB101 Capsid to Advance Gene Therapies
CHARLESTOWN, Mass., Sept. 23, 2025 — Solid Biosciences has entered a non-exclusive licensing agreement with Kinea Bio to utilize...
patient access
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FDA Accelerates First-Ever Barth Syndrome Therapy, FORZINITY™
NEEDHAM, Mass., September 19, 2025 – Stealth BioTherapeutics Inc. today announced that the U.S. Food and Drug Administration (FDA)...
FDA Approves J&J’s INLEXZO™, Redefining Bladder Cancer Care
September 9, 2025 – Raritan, N.J. – In a landmark regulatory milestone, Johnson & Johnson (NYSE: JNJ) announced U.S....
FDA Grants Breakthrough Therapy Status to Olomorasib for Lung Cancer
INDIANAPOLIS, Sept. 4, 2025 – The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olomorasib,...
Pulse Biosciences Secures FDA IDE Approval to Launch Clinical Trial of nsPFA Cardiac Surgery System for Atrial Fibrillation
Hayward, CA – September 9, 2025 – Pulse Biosciences, a pioneer in bioelectric medicine and nanosecond pulsed field ablation...
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Novartis to Acquire Tourmaline Bio, Expanding ASCVD Pipeline
September 9, 2025 – Basel – In a move set to strengthen its cardiovascular disease portfolio, Novartis announced an...
FDA Adds Modeyso (dordaviprone) to Oncology Guidelines for H3 K27M-Mutant Diffuse Glioma
September 9, 2025 – In a significant advancement for neuro-oncology, Modeyso (dordaviprone) has been included in the National Oncology...
FDA Approves Updated 2025–2026 COVID-19 Vaccines from Pfizer, Moderna, and Novavax
The FDA has approved updated COVID-19 vaccines from Pfizer/BioNTech, Moderna, and Novavax for the 2025-2026 season, targeting high-risk groups....
FDA Ends Broad Emergency Authorization, Approves Updated COVID-19 Vaccines
The FDA approved updated COVID-19 vaccines from Pfizer/BioNTech, Moderna, and Novavax while ending broad Emergency Use Authorization. Eligibility is...
AbbVie Acquires Gilgamesh Pharmaceuticals’ Bretisilocin, A Novel Psychedelic Therapy for Major Depressive Disorder
AbbVie (NYSE: ABBV) has announced a definitive agreement to acquire Gilgamesh Pharmaceuticals’ lead investigational candidate bretisilocin (GM-2505), a next-generation...
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