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

Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...

Less than two months after an accelerated approval from the FDA, a drug combination featuring Pfizer’s Braftovi has turned in ...

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

Gilead Sciences, Inc.'s strong sales growth in Veklury, Livdelzi, and Trodelvy shows promise for long-term financial success.

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

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

The colon cancer BRAFF mutation study is one of the first to be initiated under the FDA’s Project FrontRunner.

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

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 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 ...