As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

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

Here is a select list of cancer therapies approved by the FDA throughout the month of January, featuring patient populations ...

Ac-SSO110 has now received FDA orphan drug designation and investigational new drug application clearance for the treatment ...

A monthly 10 mg/mL maintenance dose of Leqembi had the same effects on mild Alzheimer’s symptoms as biweekly dose, research ...

Following a recall of grounding pads produced by Megadyne, a machinery industry company, the FDA is notifying veterinarians ...

A clinical trial comparing a one-page medication handout proposed by the U.S. Food and Drug Administration (FDA) with an ...

The FDA removed previously issued draft guidance on diversity in clinical trials from its website without public notice or ...

Avtozma, the third biosimilar to Actemra, has received FDA approval for multiple inflammatory diseases and COVID-19, ...

The FDA recently approved Vertex Pharmaceuticals Incorporated’s Journavx (suzetrigine), a first-in-class non-opioid ...

The FDA has granted Fast Track Designation to Adicet Bio’s ADI-001, an allogeneic gamma delta CAR T-cell therapy, for ...