FDA issues Valeant Pharmaceuticals a complete response letter on its NDA for latanoprostene bunod ophthalmic solution, 0.024%, an investigative intrao...
FDA clears a GE Healthcare 510(k) for the Signa Premier, a new wide bore 3.0T magnetic resonance imaging system.
New research by FDA and RTI Internationals Center for Communication Science shows promising data on a new model for presenting risk information in bro...
Federal Register notice: FDA announces the availability of 48 final product-specific guidances that recommend the design of bioequivalence studies to ...
Federal Register notice: FDA announces a 9/19 Oncologic Drugs Advisory Committee meeting to review a C.P. Pharmaceuticals supplemental NDA for Sutent.
FDA approves a Teva Pharmaceutical Industries NDA for Qvar RediHaler (beclomethasone dipropionate HFA) inhalation aerosol, a breath-actuated inhaler f...
Federal Register notice: FDA announces a 9/13 Vaccines and Related Biological Products Advisory Committee meeting that will review GlaxoSmithKline Bio...
FDA issues Vernalis a complete response letter on its NDA for CCP-08, an undisclosed extended-release product being developed for Vernalis by Tris Pha...