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 ...

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 ...

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

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

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

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

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

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