The FDA approved an expanded label for Iluvien, which is now indicated for the treatment of chronic noninfectious uveitis ...

Scienture (SCNX) announces the U.S. Food and Drug Administration, FDA, has approved SCN-102, one of the products being developed by Scienture, ...

With a U.S. green light for its encapsulated cell therapy technology in the bag, privately held biotech Neurotech ...

Feb. 25, 2025 – The FDA has approved a new treatment plan for a long-acting injection, making it easier for people with moderate to severe opioid use disorder (OUD) to start and keep up with ...

They are made by licensed pharmacies, but not approved or inspected by the FDA. Drug compounding is allowed when drugs are on the FDA's shortage list, or in circumstances when a patient can't take ...

The FDA is expected to decide on treatments for ... The Company is seeking approval for acute treatment of migraine with or without aura.

The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics,” is a game-changer for biopharmaceutical ...

ILUVIEN now approved for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) in addition to ...

Upcoming market catalysts for the second quarter of 2025 include the US approval decisions for clesrovimab (MK-1654) for respiratory syncytial virus (RSV) prophylaxis, sebetralstat for hereditary ...

The prospect of Trump officials overturning the approval of FDA-approved medicines is a growing concern for physicians, medical researchers and drugmakers. Mifepristone was approved roughly 25 ...

The FDA is reviewing the supplemental NDA for cabozantinib ... The Company is seeking approval for acute treatment of migraine with or without aura.

The FDA on Friday gave the green light to Mirum’s Ctexli, also known as chenodiol, for the treatment of adults with cerebrotendinous xanthomatosis (CTX). The approval makes chenodiol—already ...