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 ...

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 ...

Accelerated drug development and approval pathways ... including the 2015 “Opinions on the Reform of Review and Approval Process for Drugs and Medical Devices,” and the 2020 revision of ...

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

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 ...

The US Food and Drug Administration (FDA) has published new draft guidance for its Accelerated Approval Program, which provides a process for expediting new drugs that serve unmet medical needs ...

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

The notion that we can simultaneously demand expedited approvals while gutting the agency is misguided.

One of the FDA’s recently departed top officials is weighing in on the wide-ranging staff cuts at the agency and how they could imperil the drug approval process that has served as the global ...