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

On May 8, the Food and Drug Administration granted accelerated approval to the combination of avutometinib and defactinib for ...

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

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

Food and Drug Administration Commissioner Marty Makary, M.D., spoke about the need to shorten the length of the drug approval ...

The Avmapki Fakzynja Co-Pack marks the first FDA-approved treatment for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who have received prior systemic therapy. The FDA has ...

Imagine being told there’s a drug that might save your life — but your insurance won’t cover it for 18 months. That’s the ...

Treatment with the Avmapki Fakzynja Co-pack received accelerated FDA approval for previously treated low-grade serous ovarian ...

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

An estimated 70% of LGSOC tumors are driven by mutations in the MAPK pathway that regulates certain process ... is an accelerated approval made under a pathway that can get a drug to market ...

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