FDA grants AstraZenenca an accelerated approval for Etcamah (camizestrant), an estrogen receptor antagonist, in combination with a CDK4/6 inhibitor (a...
FDA approves Ionis Pharmaceuticals Zanvastro (zilganersen) injection for treating Alexander disease in pediatric and adult patients.
A Crowell & Moring analysis says FDA may increase regulatory scrutiny for user-facing GenAI-enabled devices.
FDA says helping to increase supplies of estradiol transdermal patches after reports that some patients are having difficulty finding their usual prod...
Four FDA senior officials explain how the agency is strengthening its good clinical practice oversight in an increasingly globalized clinical trial en...
FDA publishes a request for information on stakeholders views on ways to accelerate botanical drug development.
The Senate Special Committee on Aging chairman and ranking member ask the Government Accountability Office to study and assess any connection between ...
Consultants RMS suggests ways that companies can reduce the impact and risk of FDA complete response letters.
