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 on January 29, 2025.
Replimune's BLA For RP1-Nivolumab Combo Gets FDA Approval …
2 days ago · Following the announcement, Replimune's stock is currently climbing 26.09 percent, to $12.78 on the Nasdaq. ... Replimune's BLA For RP1-Nivolumab Combo Gets FDA Approval For Advanced Melanoma ...
Dyne Therapeutics Receives FDA Fast Track Designation for DYNE …
2 days ago · - Company Anticipates Submitting for U.S. Accelerated Approval in H1 2026 - WALTHAM, Mass., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage neuromuscular ...
AstraZeneca Secures FDA Nod for New ADC Drug Datroway in ... - Nasdaq
3 days ago · The FDA's nod is based on late-stage data, which show AZN's Datroway cuts the risk of disease progression/death by 37% vs chemotherapy in certain breast cancer patients.
Dyne Therapeutics Receives FDA Fast Track Designation for DYNE ... - Nasdaq
2 days ago · The FDA has granted Fast Track designation for DYNE-101, expediting its development and review process for the treatment of myotonic dystrophy type 1 (DM1). ... (Nasdaq: DYN), a clinical-stage ...
Atara stock extends losses on FDA clinical hold (ATRA:NASDAQ)
2 days ago · Grandbrothers. Shares of Atara Biotherapeutics (NASDAQ:ATRA) continued to trade lower in the premarket on Tuesday after the U.S. Food and Drug Administration (FDA) slapped the cell therapy ...
Solid Biosciences Receives FDA Fast Track Designation for SGT …
2 days ago · FDA IND clearance for SGT-212 was announced January 7 th, 2025. The planned Phase 1b trial will be a first-in-human, open-label, multicenter study to evaluate the safety and tolerability of ...
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 · 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 have received prior systemic therapy, is due on December 20, 2024.
What Foods Will Be Impacted by FDA's Red Dye No. 3 Ban | TIME
Jan 16, 2025 · The U.S. Food and Drug Administration (FDA) banned the use of Red Dye No. 3 in food and ingested drugs on Wednesday, more than three decades after the agency prohibited it from being used in ...
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