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 ...

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.

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On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...

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.

Stamford-based SpringWorks Therapeutics, a commercial-stage biotech company developing treatments for rare diseases and ...

The FDA on Tuesday signed off on SpringWorks Therapeutics’ mirdametinib—now to carry the brand name Gomekli—for the treatment ...

Dr. Tycel Phillips discusses the implications of the FDA approval of Calquence plus bendamustine and Rituxan in untreated MCL ...

Evrysdi is a non-invasive, disease-modifying option that can be swallowed whole or dispersed in water for patients with ...