FDA grants in part and denies in part an AdvantaPharma petition seeking specific requirements on ANDA holders for generic nintedanib.
FDA warns Chinas Yangzhou H&R Plastic Daily Chemical Company about CGMP violations in its production of finished drugs.
FDA warns Irvine, CA-based IsoTis OrthoBiologics about Quality System violations in its production of Accell-branded resorbable calcium salt bone void...
The Government Accountability Office recommends that FDA take steps to publicly disclose how it resolves conflict of interest and appearance issues fo...
Three experts express differing views on the reasons for and the impact of the departure of CBER director Vinay Prasad from FDA for a second time.
A Brookings commentary warns that intense price competition in the U.S. generic drug market is undermining manufacturing quality and increasing the ri...
Ocugen announces positive 12-month results from a mid-stage clinical trial of its experimental gene therapy OCU410, aimed at treating geographic atrop...
FDA sends a Warning Letter to ImmunityBio, citing misleading promotional claims about its cancer therapy Anktiva (nogapendekin alfa inbakicept-pmln) i...
