Biotech Stocks Facing FDA Decision In January 2025 - Nasdaq
Jan 2, 2025 · The FDA decision on Datopotamab Deruxtecan, proposed for the treatment of patients with previously treated metastatic HR-positive, HER2-negative breast cancer, is due …
Elicio Therapeutics Reaches Alignment with FDA on ELI-002 ... - Nasdaq
1 day ago · Received supportive FDA feedback on key elements of the potential ELI-002 Phase 3 study design, including dose, schedule, patient population and primary endpoint analysis …
Solid Biosciences Receives FDA Fast Track Designation for SGT ... - Nasdaq
2 days ago · The FDA's Fast Track designation supports expedited development and review of treatments for serious conditions, allowing more frequent communication with the agency and …
Biotech Stocks Facing FDA Decision In October 2024
Sep 30, 2024 · The FDA decision on Biofrontera's request to increase the maximally approved dosage of Ameluz from one to three tubes per treatment is expected on October 4, 2024.
Elicio Therapeutics Reaches Alignment with FDA on ELI-002 ...
1 day ago · Received supportive FDA feedback on key elements of the potential ELI-002 Phase 3 study design, including dose, schedule, patient population and primary endpoint analysis …
FDA Places Clinical Hold On Atara Biotherapeutics' Two Cell …
2 days ago · On Tuesday, the U.S. Food and Drug Administration (FDA) placed a clinical hold on Atara Biotherapeutics, Inc.’s (NASDAQ:ATRA) active Investigational New Drug (IND) …
Biotech Stocks Facing FDA Decision In December 2024
Dec 2, 2024 · The FDA decision on Datopotamab deruxtecan, proposed for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer who …
FDA Calendar and Recent FDA News - Benzinga
Benzinga's FDA calendar shows historical FDA data, upcoming dates that companies will be impacted by the FDA and ranges of dates.
Biotech Stocks Facing FDA Decision In December 2024
Dec 2, 2024 · Rhythm Pharma has sought FDA approval to expand the use of IMCIVREE to include children as young as 2 years old for its approved indications, and a decision is due on …
Companies That Recently Received FDA Approval - Health Stocks …
4 days ago · BOSTON, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming …
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