GSK’s depemokimab, a long-acting biologic that’s key in the British pharma’s growth plan, has won an endorsement from ...

Bristol Myers Squibb BMY and Gilead Sciences, Inc. GILD are leading biotechnology companies with broad, diverse portfolios ...

Shares of Bristol Myers Squibb BMY gained 5.62% after the company announced the continuation of the phase III ADEPT-2 study ...

Health care professionals can have a powerful impact on labeling requirements for drugs by formally petitioning the FDA for ...

The U.S. Food and Drug Administration has approved an updated label for Unloxcyt (cosibelimab-ipdl) for the treatment of ...

The drugs have soared in popularity, with some men taking them for unapproved uses like anti-aging or increasing muscle mass.

Cytokinetics may be counting down the days until the FDA decides whether to approve its cardiovascular drug aficamten. But, for a biotech planning to commercialize its first drug—and without Big ...

Shares in Sarepta reversed some of their recent declines after the FDA added a warning label to its Duchenne muscular dystrophy (DMD) gene therapy, ending a protracted period of uncertainty for the ...

Promo materials should also refrain from positioning one approved biosimilar as better than another for the same reference product, per the document, and they shouldn’t suggest that a biosimilar is ...

To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min The FDA has restricted the ...

Conditional approval extended through December 2026 for the treatment of CID in dogs CID confirmatory effectiveness trial expected to conclude in February 2026, ahead of FDA’s June deadline – 51 dogs ...

To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min The FDA has restricted the type ...