The results could sway U.S. regulators to convert Braftovi’s accelerated clearance in colorectal tumors into a full approval ...

Biotech giant Bristol-Myers Squibb Company BMY is scheduled to report its fourth-quarter and full-year 2024 results on Feb. 6 ...

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 ...

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

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

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) ...

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

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

The US Securities and Exchange Commission (SEC) has given initial approval for Bitwise’s spot Bitcoin (BTC) and Ethereum (ETH) Exchange-Traded Fund (ETF). The SEC confirmed that the filing received ...

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.