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

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

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 ...

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 ...

Regenxbio Inc (RGNX) reports robust financial health and strategic advancements, with a focus on potential FDA approvals and ...

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

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

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

DNLI reports a wider-than-expected loss for the first quarter of 2025. Denali submits a BLA for tividenofusp alfa under the ...

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

CEO Dr Nina Webster knows that the drug development journey is just as important as the destination when it comes to ...