Shares of Biohaven (BHVN) plunged ~37% to reach a new 52-week low on Wednesday after the company said the U.S. FDA issued a ...
Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range ...
Company to hold conference today at 8:00 a.m. -- BOSTON, Nov. 07, 2025 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc.
The U.S. FDA approved a pricey rare disease drug in September despite findings by its data reviewers that the treatment, ...
October 2025 proved to be a significant month for the oncology landscape, marked by a wave of key regulatory decisions from ...
The U.S. Food and Drug Administration is reviewing a new Parkinson's disease drug called tavapadon that could give people ...
Experimental pill versions of GLP-1 weight loss drugs by Novo Nordisk and Eli Lilly will receive FDA priority review. Read ...
The FDA’s effort to expedite reviews for drugs in line with the Trump administration’s priorities was greeted warmly by a ...
Submission supported by data from the Phase 3 TEMPO program that demonstrated symptomatic improvement across the Parkinson's disease spectrum Positive results across all three Phase 3 TEMPO trials ...
The FDA has named six new additions to the Commissioner’s National Priority Voucher (CNPV) program, expanding the initiative to 15 products that address critical public health and national security ...
Biosimilar developers should expect case-by-case evaluations, as the draft offers no hard rules on when CES will be waived. Developers are encouraged to consult the FDA early to understand evidentiary ...
FDA approved a pricey rare disease drug in September despite findings by its data reviewers that the treatment, while safe, ...
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