The FDA granted accelerated approval to the tyrosine kinase inhibitor sunvozertinib (Zegfrovy) for advanced non-small cell ...

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) is one of the most undervalued large cap stocks to buy according to analysts. On ...

ProKidney shares surged 500% on positive Phase 2 CKD results. Read why I remain cautious about PROK stock despite the recent ...

Regeneron Pharmaceuticals has won FDA accelerated approval of its Lynozyfic treatment for certain patients with the blood ...

The FDA has granted accelerated approval to Datroway for adults with previously-treated, locally advanced or metastatic EGFR-mutated NSCLC.

Two recent accelerated approvals have raised more questions of whether the FDA has lowered the bar too far. Science & Medicine. FDA approves much-debated Alzheimer’s drug panned by experts.

The accelerated approval pathway works, though it isn't a flawless oracle of therapeutic success. Perfect mustn't be allowed to be the enemy of people with unmet needs.

The accelerated approval process speeds medicines to market based on preliminary study data. But there's a condition: The drugmaker needs to do an additional study after the drug is on the ...

The U.S. Securities and Exchange Commission has reportedly asked issuers behind proposed Solana (SOL-USD) exchange-traded ...

Accelerated approval was based on results from the Phase I/II LINKER-MM1 trial, which showed a 70% objective response rate in ...

Regeneron Pharmaceuticals’ Lynozyfic (linvoseltamab-gcpt) has been granted accelerated approval by the US Food and Drug ...