It was early November. The Food and Drug Administration had just endured the high-profile, dramatic exit of its top drug regulator. Personnel complaints had racked up. And other grievances within the ...

The US FDA is advancing the drug approval process for sibeprenlimab, a novel targeted drug to help manage immunoglobulin A nephropathy (IgAN).

Belite linked tinlarebant to a 35.7% reduction in lesion growth rate versus placebo, achieving the study’s primary endpoint.

Phoenix NP announced an expansion of its service availability across Arizona to help more women access FDA-approved GLP-1 weight loss medications through compliant, manufacturer-direct pharmacies. The ...

AxoGen ( ($AXGN) ) has shared an update. On December 3, 2025, Axogen announced that the FDA approved its Biologics License Application for ...

A new FDA approval for a first-in-class drug has vaulted Otsuka into immunoglobulin A nephropathy (IgAN), an increasingly competitive kidney disease field targeted by multiple biopharma companies.

FDA lowers surveillance requirement to 50 patients from 300 patients in original HDE approval based on assessment of first 21 SAVE Surveillance ...

The FDA approved Truvian's new Tru-Verus machine, which can run nearly three dozen common blood tests right in a doctor's ...

Please provide your email address to receive an email when new articles are posted on . Recent FDA actions include approval of the first new treatment for acute stroke in 30 years. FDA also cleared a ...

With another inflammatory bowel disease (IBD) approval in the bag for Tremfya, Johnson & Johnson continues to make good on the succession plan for its declining autoimmune blockbuster Stelara.

The Food and Drug Administration (“FDA”) has removed semaglutide from its drug shortage list after the agency determined the current supply of the drug can meet present and future demand. On February ...