[ Price : $8.95]
Telix Pharmaceuticals refiles an NDA seeking approval of its investigational PET imaging agent Pixclara (TLX101-Px, also known as ...[ Price : $8.95]
FDA inspectors cite multiple manufacturing and quality control deficiencies at a Gland Chemicals Private Limited in Chennai, India...[ Price : $8.95]
FDA updates an internal policy document outlining how CBER staff process supplements to approved drug and biologic applications.[ Price : $8.95]
NRx Pharmaceuticals says FDA has indicated it is willing to review a potential NDA for its investigational therapy NRX-100 without...[ Price : $8.95]
FDA has told NovaBridge Biosciences that its investigational cancer therapy givastomig could be eligible for an accelerated approv...[ Price : $8.95]
FDA accepts for review a Sun Pharmaceutical Industries supplemental BLA seeking to expand the use of Ilumya (tildrakizumab-asmn) t...[ Price : $8.95]
A regulatory consulting firm's report finds that FDA sharply increased enforcement activity against drugmakers and distributors in...[ Price : $8.95]
A legal update from ArentFox highlight several emerging regulatory and enforcement developments at FDA thatare expected to have si...