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IONS Up on FDA's Breakthrough Tag for ION582 in Angelman Syndrome

Ionis Pharmaceuticals IONS announced that the FDA has granted the Breakthrough Therapy designation to its pipeline candidate, ION582, for the treatment of Angelman syndrome (AS), a rare neurological ...

FDA's Controversial Approval of $800,000 Rare Disease Drug Sparks Debate

In September, the U.S. FDA approved Stealth Biotherapeutics' elamipretide, branded as Forzinity, for Barth syndrome despite mixed reviews on its efficacy. Priced at $800,000 yearly, the decision was ...

Disc Medicine Announces Receipt of FDA Commissioner’s National Priority Voucher (CNPV) for Bitopertin in Erythropoietic Protoporphyria (EPP)

WATERTOWN, Mass., Oct. 16, 2025 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel ...

FDA's top drug regulator sued by Canadian pharmaceutical company

Dr. George Tidmarsh, the Food and Drug Administration’s top drug regulator, was placed on administrative leave and is considering resigning, citing a “toxic” environment.

Revolution Medicines Awarded Voucher for Daraxonrasib (RMC-6236) Under FDA Commissioner's National Priority Voucher Pilot Program

REDWOOD CITY, Calif., Oct. 16, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted ...

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