Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...

The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...

Vertex Pharmaceuticals (NASDAQ: VRTX) just snagged its second U.S. Food and Drug Administration (FDA) approval in only 41 ...

Day One Biopharma's OJEMDA FDA approval for pediatric glioma, but market concerns remain. Check out why I rate DAWN stock as ...

The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.

LEXINGTON, Mass. - uniQure N.V. (NASDAQ: NASDAQ:QURE), a gene therapy company with a market capitalization of $767 million, ...

The SEC's “accelerated approval” grants NYSE Arca to list and trade shares of the hybrid Bitwise's Bitcoin and Ethereum fund.

Unsurprisingly, Akero owes this incredible one-day gain to data from a midstage clinical trial. Akero Therapeutics is ...

HHS also looked into a system that would have incentivized manufacturers to “expedite and complete confirmatory clinical ...

FDA aligned on single-arm Phase 3 study to support potential accelerated and full approval On track to dose first patient in Phase 3 trial in second half of 2025 LONDON, Feb. 03, 2025 (GLOBE NEWSWIRE) ...

The Food and Drug Administration (FDA) has approved a new maintenance dosing schedule for Leqembi, a monoclonal antibody ...