"We are pleased the FDA has accepted our NDA for Bumetanide Nasal Spray," said Benjamin Esque, CEO of Corstasis Therapeutics ...

The FDA has accepted for review the New Drug Application for plozasiran for the treatment for familial chylomicronemia syndrome.

The Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for elamipretide for the treatment of Barth syndrome, a rare genetic disorder.

Trump rescinded Executive Order 14087, "Lowering Prescription Drug Costs for Americans," which directed Medicare and Medicaid ...

The FDA rejected the company’s initial NDA in 2021, citing the lack of an adequate trial to demonstrate efficacy.

The FDA has accepted the BLA for lecanemab-irmb SC for weekly maintenance dosing in the treatment of early Alzheimer disease.

Since the announcement that president-elect Donald Trump would nominate Robert F. Kennedy Jr. (RFK Jr.) as the secretary of the U.S. Department ...

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the U.S. Food and Drug Administration (FDA) has granted Orphan ...

Separate provisions in the Inflation Reduction Act of ... 2000-prescription-drug-cap-january-1-2025-how-it-works/. Sayed, Bisma A., et al. Medicare Part D Enrollee Vaccine Use after Elimination ...

Shares of Replimune Group, Inc. (NASDAQ: NASDAQ: REPL) surged 17% following the announcement that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for ...

Kennedy Jr. possibly use his authority as HHS secretary ... the FDA’s deadlines to respond to drug applications — known as a Prescription Drug User Fee Act date. “We believe it is reasonably ...

The confirmatory IGNYTE-3 trial is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for ...