Lyell Immunopharma (NASDAQ:LYEL) President and CEO Lynn Seely outlined the company's clinical development priorities, ...
The FDA has delayed its approval decision on Beren Therapeutics’ rare disease drug candidate, extending the asset’s long path ...
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FDA grants priority review to SNY's filing for Gaucher disease drug
Sanofi SNY announced that the FDA has accepted its new drug application (NDA) seeking approval for venglustat, an investigational oral glucosylceramide synthase inhibitor, for the treatment of ...
The US Food and Drug Administration (FDA) published the internal checklists its staff reference when reviewing drug and biologics applications to determine whether the submission is complete, or ...
FDA stated that the “proposed data may be capable of supporting the submission and review of an [NDA] under the accelerated approval pathway” for ...
The FDR outcome directs FDA divisions to finalize labeling with the sponsor, reversing the prior CRL trajectory and ...
WASHINGTON — The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with Nobel Prize-winning mRNA technology, the company announced Tuesday. The ...
BridgeBio Pharma has taken another step toward the potential approval of its muscle weakness drug candidate BBP-418, reporting statistically significant phase 3 efficacy data that analysts have deemed ...
WOBURN, Mass., Feb. 11, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the commercialization and development of ...
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