[ Price : $8.95]
FDA releases a draft guidance that outlines recommendations for developing potency assays for active immunotherapy products, inclu...[ Price : $8.95]
FDA warns Pomona, CA-based K.C. Pharmaceuticals about repeat CGMP violations in the production of over-the-counter drugs.[ Price : $8.95]
Merck and Moderna say a Phase 3 trial of Keytruda and intismeran autogene met key endpoints as an adjuvant melanoma treatment.[ Price : $8.95]
FDA warns Indias Auriga Research contract testing laboratory about CGMP violations in its testing of drugs for clients.[ Price : $8.95]
FDA publishes a guidance with frequently asked questions on the development of cellular and gene therapy products.[ Price : $8.95]
FDA grants Vitestro a de novo authorization for Aletta, the first standalone robotic device designed to draw blood from a patients...[ Price : $8.95]
FDA accepts for review a Teva Pharmaceuticals NDA for ecopipam, indicated for treating pediatric patients with Tourette syndrome.[ Price : $8.95]
FDA cites Neeyaan LLC for multiple GMP deficiencies, including the firms failure to validate drug manufacturing processes, conduct...