Regeneron announced the FDA’s approval of two indications of Eylea HD, including an 8mg injection for patients with macular ...

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...

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

Pregnant people have a higher risk of severe disease and death from COVID, so making it harder for them to get vaccinated ...

Federal officials have approved another generic version of the abortion pill mifepristone, a regulatory formality that quickly triggered pushback from anti-abortion groups and politicians aligned with ...

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.

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

The U.S. Food and Drug Administration said on Wednesday that it has approved Bayer's drug for patients with a form of lung ...

The FDA approval of the siRNA drug Redemplo caps off a tumultuous 12 months for Arrowhead, whose partnership with Sarepta ...

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 ...

In the midst of the rising popularity of glucagon-like peptide-1 receptor agonists (GLP-1RAs), and their compounded versions, the US Food and Drug Administration (FDA) has been stepping up its efforts ...

Please provide your email address to receive an email when new articles are posted on . An update to the FDA drug shortage list on Feb. 21 listed the semaglutide shortage as being resolved. In a press ...