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

The NDA is supported by data from a clinical trial that compared the absorption and efficacy of the nasal treatment with oral and IV bumetanide in 68 healthy adults.

The US Food and Drug Administration has approved the supplemental biologics licence application (sBLA) of Eisai and Biogen's ...

Merck (MRK) announced the U.S. FDA has accepted for priority review a supplemental new drug application seeking approval of Welireg, Merck’s ...

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for belzutifan for the treatment of adult and pediatric patients aged 12 years and ...

A monthly 10 mg/mL maintenance dose of Leqembi had the same effects on mild Alzheimer’s symptoms as biweekly dose, research ...

A Prescription Drug User Fee Act (PDUFA) action date is August 31, 2025. The BLA is based on data from the Clarity AD (Study ...

The supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...

Trump rescinded Executive Order 14087, "Lowering Prescription Drug Costs for Americans," which directed Medicare and Medicaid ...

“We are pleased the FDA has accepted our NDA for Bumetanide Nasal Spray,” said Benjamin Esque, CEO of Corstasis Therapeutics Inc. “This milestone brings us closer to providing a simple, easy-to-use ...

Viral social media posts claim that one of the orders revoked was one that lowered prescription drug costs for people ...