Here’s how drug developers can best approach interactions with the agency following last year’s seismic changes to its ...

Infrastructure and location have helped make Holly Springs a future hub for obesity drug production, with Amgen and Roche ...

FDA decisions lack majority consensus, experts agree, possibly leading to less nuanced verdicts on new drug applications.

Less than a year after cutting roughly 30% of its employees, BioAtla is letting go of an even larger chunk of its workforce ...

Days after FDA Commissioner Marty Makary appeared to malign uniQure’s AMT-130 in an interview with CNBC, the agency confirmed ...

As Novo Nordisk continues to lose ground in the obesity market to rival Eli Lilly, the Danish company has started ...

Aardvark Therapeutics is down 54% since Friday after the biotech said it detected “reversible cardiac observations” in a ...

Yuviwel will compete with BioMarin’s Voxzogo. Meanwhile, BridgeBio is working to bring its own achondroplasia drug, the FGFR3 ...

One of the two new members of the CDC's Advisory Committee on Immunization Practices questioned the safety of COVID-19 ...

Generate:Biomedicines has hit the public markets as the world begins to question the usefulness of AI technology. CEO Mike Nally says biology is the key to unlocking the technology’s full potential.

A combination of Merck’s Keytruda and Pfizer’s Padcev could offer a chemotherapy-free treatment alternative for patients with ...

On the FDA’s docket this month are two decisions pushed back from 2025, including one for a rare form of obesity and another ...