GSK (GSK) announced that new drug applications have been accepted for review by the China National Medical Products Administration and ...

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 ...

January 17, 2025--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has accepted the New Drug Application ...

The FDA’s nod for suzetrigine bolsters confidence in the pharmaceutical industry’s strategy to target sodium channels.

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 list, which includes 15 drugs, up from 10 last year, is the first step in a negotiation process between Medicare and drugmakers that is expected to take place over the coming months. The new ...

CMS had until Feb. 1 to announce the new batch of drugs chosen for negotiation. When asked if the new selection was announced early in anticipation of the incoming Trump administration ...

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 ...