Matthew Herper joins Adam and Allison to examine Prasad’s appointment and the band of outsiders now in charge of U.S. health ...

The FDA has granted accelerated approval to avutometinib (VS-6766) plus defactinib (VS-6063) for the treatment of adult ...

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...

The FDA's decision to appoint Vinay Prasad, MD, MPH, to head its Center for Biologics Evaluation and Research (CBER) raised ...

FDA Commissioner Marty Makary’s proposal to roll out a new drug approval pathway is heightening hope for the rare disease ...

The use of RWD data in place of placebo groups is improving various elements across the clinical trial space.

Following massive layoffs and cuts at the FDA, Makary’s plan for the agency is yet to fully unfold. But he has hinted at what ...

FDA names Vinay Prasad to lead CBER, raising questions over biologics oversight and triggering biotech stock losses and ...

A "productive" meeting with the FDA has given the firm confidence in its regulatory filing and commercialization plans for ST-920.

Key Insights for Pharma Manufacturers Regarding the AKS - In a series of recent legal challenges initiated by the ...

Radiopharma biotech Cellectar Biosciences is seeking strategic alternatives, opening the door to further opportunities after ...