The Food and Drug Administration (FDA) approved a new drug to treat a disorder causing the growth of noncancerous tumors on ...

The U.S. Food and Drug Administration said on Tuesday it has approved SpringWorks Therapeutics' drug to treat a type of rare ...

The US Food and Drug Administration (FDA) has approved SpringWorks Therapeutics’ Gomekli (mirdametinib) to treat ...

The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA ...

Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...

Nexus Pharmaceuticals, LLC announces the U.S Food and Drug Administration (FDA) approval of Tacrolimus Injection 5 mg/mL. Nexus’ Tacrolimus Injection is the first and only vial that will be available.

The FDA on Thursday approved a new class of pain medication that provides an alternative to opioids. It will be sold under ...

Evolus said on Thursday the U.S. Food and Drug Administration has approved its two new anti-wrinkle injectable gels, expanding the company's product portfolio beyond its cosmetic injection Jeuveau.

On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...

FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective," the letter stated. The FDA isn’t criticizing dietary supplements in ...

Evolus said the Food and Drug Administration approved its injectable hyaluronic acid gels, known as Evolysse Form and Evolysse Smooth, in line with management expectations.

FDA 2025 pulmonology drug alerts, including drug approvals/warnings, vaccine approvals, and medical device recalls/updates.