“It would not be surprising to not see new FDA guidance documents issued for some period of time,” said David Larwood, CEO of Valley Fever Solutions, about the potential impact of the US Food and Drug ...

Forbes contributors publish independent expert analyses and insights. Greg Licholai writes and teaches about innovation in healthcare. In a move that could dramatically reshape the landscape for rare ...

~ U.S. Food and Drug Administration (FDA) agrees that data from ongoing Phase I/II studies compared to a natural history external control may serve as the primary basis for a Biologics License ...

Accelerated drug development and approval pathways, designed to expedite the delivery of essential medicines for patients with serious and rare diseases, have been successfully implemented in the ...

Avutometinib plus defactinib granted priority review by FDA, under the accelerated approval pathway, for recurrent KRAS mutant LGSOC; PDUFA action date set for June 30, 2025 Potential U.S. commercial ...