Jan 31, 2025 · Let's take a look at the biotech stocks awaiting FDA decisions in February. Supernus Pharmaceuticals Inc. (SUPN) The FDA decision on Supernus Pharma's SPN-830, an investigational apomorphine ...

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.

1 day ago · (RTTNews) - Eton Pharmaceuticals Inc (ETON), a company focused on developing treatments for rare diseases, on Thursday, announced that the FDA has postponed the decision on the New Drug ...

3 days ago · ROCKVILLE, Md., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of ...

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.

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.

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.

Benzinga's FDA calendar shows historical FDA data, upcoming dates that companies will be impacted by the FDA and ranges of dates.

4 days ago · SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. -- (BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application (IND) to initiate a clinical study of the company’s investigational UKidney™ derived from a 10 gene-edited source pig. The ...

5 days ago · Vertex Pharmaceuticals (NASDAQ: VRTX) just snagged its second U.S. Food and Drug Administration (FDA) approval in only 41 days. On Dec. 20, 2024, the FDA gave a thumbs-up to Alyftrek in treating ...