FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...

The director of the U.S. Food and Drug Administration's Center for Drug Evaluation and Research, George Tidmarsh, resigned on Sunday amid serious concerns about his personal conduct, a Department of ...

The head of the Food and Drug Administration’s drug center abruptly resigned Sunday after federal officials began reviewing “serious concerns about his personal conduct,” according to a government ...

UniQure , said on Monday its experimental gene therapy for Huntington's disease does not have adequate clinical data to ...

The FDA's top drug regulator, Dr. George Tidmarsh, quit after federal officials began reviewing "serious concerns about his ...

Anil R. Diwan, PhD, President and Executive Chairman of the Company will provide an update on the Company, its Drug Pipeline ...

Dr. George Tidmarsh, the Food and Drug Administration’s top drug regulator, was placed on administrative leave and is ...

The New Jersey-based Ascend Laboratories recalled 140,000 tablets of Atorvastatin Calcium. Pharmacies sold the statin drug as ...

Science must guide treatment decisions, and healthcare practitioners must take decisive action now to stop inappropriate fibrate prescribing for cardiovascular risk reduction, especially on top of ...

The FDA approved nerandomilast (Jascayd) tablets for idiopathic pulmonary fibrosis (IPF), the first new product for the progressive lung condition in over a decade, the agency announced on Tuesday.

Rybelsus® (semaglutide) tablets 7 mg or 14 mg, the only FDA-approved oral GLP-1 medicine available, now indicated to reduce the risk of major adverse cardiovascular events ...