In a warning letter posted online late last month, the FDA scolded Viatris over a range of production slights at the ...

In recent years, the FDA has amped up its supervision of accelerated approvals, including by requiring that confirmatory ...

From condemning the Jan. 6 Capitol riots to helping fund the President-elect’s impending inauguration, recent years have seen ...

In Ireland, WuXi Biologics has sold a new vaccines plant to Merck & Co. for €500 million ($521 million). The New Jersey ...

After nabbing an FDA approval last summer for its T-cell lymphoma treatment Lymphir, Citius Oncology is eyeing strategic ...

Comedian Nikki Glaser, host of the 2025 Golden Globe Awards ceremony, dove right in at the start of her opening monologue: ...

Amylyx Pharmaceuticals has named Dan Monahan as chief commercial officer, positioning an exec who led the U.S.

Welcome to Fierce Pharma's regulatory tracker for the first half of 2025. | In this tracker, Fierce Pharma is recording the ...

In a citizen petition posted by the FDA this week, Novo urged the regulator to restrict the ability of compounding pharmacies ...

The German drugmaker will pay the NIH $791.5 million, while the University of Pennsylvania will get up to $467 million ...

In separate DLL3 antibody-drug conjugate (ADC) deals, Roche licensed from Innovent Biologics and Ideaya reached for Hengrui.

The story of Eli Lilly and Novo Nordisk’s GLP-1 dominance is likely to play out again in 2025 as the metabolic medicine ...