Kennedy's MAHA-aligned policy grants enforcement discretion for peptides that won a contested FDA advisory panel recommendation in July, despite objections from

The highest dose of the triple-G drug outperformed Novo's Ozempic, though with higher side effects and discontinuations, reinforcing expectations it will be a m

The framework creates an approval path for personalized therapies serving subsets of patients with the same disease, building on recent FDA moves to speed rare-

The late-stage success lifts shares and props up the large acquisition Genmab made to secure the cancer drug.

The results mark a significant step for individualized cancer vaccines and could reshape melanoma treatment.

Reviewers and clinicians are weighing infection concerns as the agency nears its approval decision for the candidate.

The approval adds a functional cure option to a viral disease that affects hundreds of millions worldwide.

The setback hits one of the top-performing biotech stocks and clouds its tumor-infiltrating lymphocyte franchise beyond melanoma.

An exemption for a common type of licensing deal is central to the disagreement over the proposal's impact on drug development.

Etiome, Cellarity and Empress Therapeutics combine into a company claiming better prediction of how new medicines will perform in humans.

The HHS secretary is staking his movement's future on an election that will shape health policy.

The deal hands Ferring rights to technology aimed at simplifying the lengthy in vitro fertilization process.

Dana-Farber research offers clues to the rising incidence and aggressiveness of colorectal cancer in younger people.

The company's closure follows fatal safety events in its cell therapy study for autoimmune disease.

A federal judge ruled Novo failed to prove Lilly's superiority claims meaningfully harmed Wegovy sales.

Rare-disease status could qualify the drug for seven years of US market exclusivity if approved.

The German company's expansion comes as its oncology pipeline results remain mixed.