The agency’s main drug review office cleared 50 novel medicines last year, short of 2018’s record total but on the higher end ...

Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory decisions.

Vertex Pharmaceuticals offers promising opportunities in pain management, cystic fibrosis treatments, and a diversified ...

WHITE OAK, MD - JULY 20: A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. This story was originally published on BioPharma Dive.

The early approval of vanza triple, or Alyftrek, is “positive, but was largely expected,” adds the analyst, who sees upside from pipeline updates in 2025. Published first on TheFly – the ul ...

The FDA’s Center for Drug Evaluation and Research (CDER) approved 50 new small molecules, biologics and oligonucleotide therapeutics last year. The class of 2024 was a little smaller than that ...

Russia and other hostile states have become increasingly brazen in adopting “gray zone” attacks against Europe and the United States, leaving defense officials with a dilemma: How to respond ...

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