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...
FDA grants in part and denies in part an AdvantaPharma petition seeking specific requirements on ANDA holders for generic nintedanib.
FDA requires an updated safety warning for Parkinsons drug products containing carbidopa/levodopa due to their potential to cause vitamin B6 deficienc...
Pfizer and Valneva plan to submit a BLA for their investigational Lyme disease vaccine candidate based on data demonstrating more than 70% efficacy in...
