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...
A Nature editorial says FDA needs help from academic scientists to review and approve new drug therapies because in-house talent is weak.
FDA clears a Mauna Kea Technologies 510(k) for its CelioFlex UHD Confocal Miniprobes for use with the companys Cellvizio laser endomicroscopy platform...
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...