The regulatory agency will review MSD’s new drug application (NDA) for Welireg under a Priority Review, with a Prescription ...

Biologics License Applications for AVT05, their proposed biosimilar to the anti-inflammatory drugs Simponi and Simponi Aria. Review of the applications is expected to by completed in Q4 2025, ...

The FDA has accepted Merck's (MRK) supplemental NDA with priority review for its drug Welireg for the treatment of a rare ...

An ustekinumab biosimilar to Stelara launched in France, completing its rollout across 5 major European markets and paving ...

Biogen BIIB announced that the FDA has approved a monthly maintenance dosing version for its intravenously (IV) administered ...

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

(HealthDay News) — The US Food and Drug Administration has approved Spravato (esketamine) CIII nasal spray for adults living with major depressive disorder who have had an inadequate response to at ...

Following an extensive scientific review, the US Food and Drug Administration has authorized the marketing of 20 ZYN nicotine pouch products.

TAVIPILOT Soft is said to be a ‘world-first’ provision for real-time surgical guidance during TAVI and TAVR procedures.

The Food and Drug Administration (FDA) recently approved the nasal spray Spravato for the treatment of major depression in ...

Biogen and Eisai have won Food and Drug Administration approval of an intravenous maintenance dosing of their Leqembi drug for early Alzheimer's disease. The companies late Sunday said the FDA ...

The Japanese pharma had one asset rejected by the FDA and withdrew a regulatory application for another, but already this ...