Potential blockbusters and root-cause treatments from Eli Lilly, Merck, Takeda and others could get a regulatory nod this ...
46 new molecular entities cleared the agency’s hurdles last year, 4 fewer than in 2024 ...
The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...
Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...
The FDA granted Priority Review to the supplemental New Drug Application (sNDA) for lurbinectedin in combination with atezolizumab as a first-line maintenance treatment for patients with ...
Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. WASHINGTON — The Food and Drug ...
ABC News' Dr. Tara Narula shares what patients need to know. Most compounded versions of popular drugs used for weight loss including Wegovy and Zepbound may soon no longer be available after a U.S.