FDA releases a draft guidance that outlines recommendations for developing potency assays for active immunotherapy products, including personalized ca...
FDA warns Pomona, CA-based K.C. Pharmaceuticals about repeat CGMP violations in the production of over-the-counter drugs.
Merck and Moderna say a Phase 3 trial of Keytruda and intismeran autogene met key endpoints as an adjuvant melanoma treatment.
FDA warns Indias Auriga Research contract testing laboratory about CGMP violations in its testing of drugs for clients.
FDA publishes a guidance with frequently asked questions on the development of cellular and gene therapy products.
FDA grants Vitestro a de novo authorization for Aletta, the first standalone robotic device designed to draw blood from a patients arm without hands-o...
FDA accepts for review a Teva Pharmaceuticals NDA for ecopipam, indicated for treating pediatric patients with Tourette syndrome.
FDA warns Indias Eugia Pharma about CGMP violations at its drug manufacturing facility in Kolthur Village.
