A new twice-yearly shot could be a "game changer" in the fight against AIDS, but experts' hopes have dimmed because of the ...

Earlier, in January 2025, the FDA released a companion piece of draft guidance titled “Considerations for the Use of ...

Donanemab was approved by the FDA in July 2024 to treat adults with early symptomatic Alzheimer's disease with confirmed ...

Eight years after it was established partly by AstraZeneca, Dizal Pharmaceuticals has gained its first FDA approval, winning an accelerated nod for Zegfrovy (sunvozertinib) to become the only ...

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

Opinion How we plan to cut FDA drug approval time by months Qualifying manufacturers will be able to submit some data while clinical trials are ongoing.

Pembrolizumab, an immune checkpoint inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with resectable locally advanced head and neck ...

Merck has received approval from the Food and Drug Administration to expand use of its blockbuster drug, Keytruda, to treat head and neck cancers.

The FDA expanded its approval of Moderna's RSV vaccine on Thursday to include adults under age 60 at increased risk of the disease.

In May, the FDA granted significant drug approvals across various therapeutic areas, marking notable progress in expanding treatment options for patients.

The US Food and Drug Administration will meet its drug approval targets this year despite cutting thousands of staff, the agency’s commissioner said.