Wen Shuhao helped speed up the development of Pfizer’s Covid oral drug, Paxlovid. Now the chairman of Xtalpi wants to help ...

Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications. The biotechnology company said the FDA put a hold on ...

The revision of labeling for products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug referenced in the ANDA.

The new drug, amycretin, similar to the company's blockbuster weight-loss and diabetes drugs Wegovy and Ozempic, provided weight loss of up to 22% in early-stage clinical trials. The company ...

The Food and Drug Administration (FDA) has accepted a new drug application (NDA) with priority review for the investigational next-generation ROS1 tyrosine kinase inhibitor (TKI) taletrectinib in the ...

If you weren't convinced we're spiraling toward an actual cyberpunk future, a new bill seeking to let AI prescribe controlled drugs just might. The proposed law was introduced in the House of ...

Diabetes and weight loss drugs Ozempic and Wegovy have been added to the list of medications selected for Medicare price negotiations, federal health officials announced Friday. The negotiations ...

The FDA is reviewing new vaccines for meningitis and chikungunya and therapies for Parkinson disease and PTSD.

Diabetes and weight loss drugs Ozempic and Wegovy have been added to the list of medications selected for Medicare price negotiations, federal health officials announced Friday. The negotiations for ...

Top doctors raised concerns about domestically made drugs, saying Beijing’s effort to lower costs is sacrificing quality. By Alexandra Stevenson and Zixu Wang Reporting from Hong Kong A rare ...