FDA official’s ouster sends shares of vaccine makers sliding

Shares in Moderna, Vaxcyte, Novavax and BioNTech all fell Monday after Peter Marks, head of the FDA office that reviews vaccines, resigned on Friday.

FDA approves first-of-its-kind RNA drug for hemophilia

The Sanofi drug, known as fitusiran and now Qfitlia, was approved on Friday for a broad group of people with the rare bleeding disorder.

Inside the world of cell therapies

FDA broadens use of Novartis’ radiopharma drug Pluvicto

Pluvicto can now be used before chemotherapy to treat a kind of metastatic prostate cancer, tripling the number of patients who are eligible for treatment.

Lilly hits same Alzheimer’s roadblock in Europe as Eisai, Biogen

Key regulators are not recommending Lilly’s Kisunla be cleared for the European market. The company says it plans to appeal the verdict, a strategy successfully employed by Eisai.

First Prader-Willi drug to reduce hunger approved by FDA

Clearance of Vykat unlocks what analysts anticipate will be a lucrative market opportunity for Soleno Therapeutics.

Judge overturns FDA’s lab developed test regulation, siding with industry

A Texas judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS Secretary Robert F. Kennedy Jr.

Leqembi’s EU review drags on; Sanofi gets a new development head

The European Commission has referred Eisai and Biogen’s application to an appeals committee. Elsewhere, Opthea warned of insolvency and Novartis hired a new top lawyer.