Following the president’s recent executive order dismantling diversity, equity, and inclusion policies, the main page for the ...

On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...

The U.S. Food and Drug Administration has approved Axsome Therapeutics' Symbravo (meloxicam and rizatriptan) for the acute ...

The U.S. Food and Drug Administration has approved Genentech's Susvimo (ranibizumab) 100 mg/mL for treating diabetic macular ...

Seven months after the FDA signed off on a reintroduction of Roche’s eye implant Susvimo, the U.S. regulator has broadened ...

An effort two decades in the making, Vertex Pharmaceuticals Inc.’s suzetrigine gained U.S. FDA approval as the first drug targeting the NaV1.8 pain signal. Branded Journavx, the oral small molecule is ...

The U.S. Food and Drug Administration said it approved Vertex Pharmaceuticals’ Journavx for short-term pain that often ...

VectorBuilder's partner, Ucello, announced that its CD19-targeting umbilical cord blood-derived allogeneic CAR-T cell therapy, UC101, received Investigational New Drug (IND) approval from the U.S.

The FDA also gave its nod to Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride), the first new class of antischizophrenia drug to be approved in decades. Roughly one-third of last ...

Advances in CRISPR technologies promise to accelerate the burgeoning pipeline of gene-editing therapies and broaden access to these disease-altering therapies.