Telix Pharmaceuticals refiles an NDA seeking approval of its investigational PET imaging agent Pixclara (TLX101-Px, also known as 18F-FET) for evaluat...
FDA inspectors cite multiple manufacturing and quality control deficiencies at a Gland Chemicals Private Limited in Chennai, India, manufacturing faci...
FDA updates an internal policy document outlining how CBER staff process supplements to approved drug and biologic applications.
NRx Pharmaceuticals says FDA has indicated it is willing to review a potential NDA for its investigational therapy NRX-100 without requiring additiona...
FDA has told NovaBridge Biosciences that its investigational cancer therapy givastomig could be eligible for an accelerated approval pathway following...
FDA accepts for review a Sun Pharmaceutical Industries supplemental BLA seeking to expand the use of Ilumya (tildrakizumab-asmn) to treat adults with ...
A regulatory consulting firm's report finds that FDA sharply increased enforcement activity against drugmakers and distributors in fiscal year 2025, i...
A legal update from ArentFox highlight several emerging regulatory and enforcement developments at FDA thatare expected to have significant implicatio...
