Biotech Stocks Facing FDA Decision In January 2025 - Nasdaq
Jan 1, 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.
Pharma Stock Roundup: JNJ's Q4 Earnings, FDA Nod to AZN ... - Nasdaq
1 day ago · Key Takeaways. JNJ beat Q4 estimates for both earnings and sales, with earnings of $2.04 per share and $22.5 billion in sales. The FDA granted approval to AstraZeneca/Daiichi's Dato-DXd for ...
Biogen Inc. Announces FDA and EMA Acceptance of Higher Dose ... - Nasdaq
2 days ago · Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and the European Medicines Agency (EMA) has ...
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.
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.
Biotech Stocks Facing FDA Decision In November 2024
Oct 30, 2024 · The FDA decision on Autolus Therapeutics' Obe-cel, proposed for the treatment of patients with relapsed/refractory adult B-cell acute lymphoblastic leukemia, is expected on November 16, 2024.
FDA Calendar, FDA Drug Approval, PDUFA Calendar - RTTNews
Get daily updates on important FDA approval, PDUFA dates, and FDA Advisory Committee Meetings with RTTNews FDA Calendar & Upcoming Approvals.
FDA Calendar • BioPharmCatalyst
Comprehensive suite of tools for trading and investing in biotech stocks. FDA Calendar, PDUFA Date Calendar, Biotech Company Screener and Database and much more.
Biotech Stocks Facing FDA Decision In September 2024
Sep 1, 2024 · The FDA is scheduled to determine whether or not to convert accelerated approval of Travere Therapeutics' Filspari to a traditional approval on September 5, 2024.