Public Citizen calls on FDA to order Amags Makena off the market because it is ineffective at reducing the rate of some pre-term births.
FDA warns Herbal Healer Academy about multiple violations of the Federal Food, Drug, and Cosmetic Act involving many of its homeopathic drugs and diet...
FDA awards $4.1 million to fund two new research grants for natural history studies in rare diseases to help design efficient clinical trials.
FDA classifies as Class 1 a Medtronic recall of its 6 French Sherpa NX Active Guide Catheter due to a risk of the outer material separating from the d...
Stakeholders generally praise a revised ICH guideline on clinical studies and suggest changes.
FDA releases its latest batch of Warning Letters that includes Herbal Healer Academy and NuCare Pharmaceuticals.
FDA approves a Clinuvel NDA for Scenesse (afamelanotide) for increasing pain-free light exposure in adult patients with a history of phototoxic reacti...
California becomes the first state in the nation to approve a bill to combat so-called pay-for-delay agreements between innovator and generic drug com...