FDA accepts for review a Sun Pharmaceutical Industries supplemental BLA seeking to expand the use of Ilumya (tildrakizumab-asmn) to treat adults with ...
Telix Pharmaceuticals refiles an NDA seeking approval of its investigational PET imaging agent Pixclara (TLX101-Px, also known as 18F-FET) for evaluat...
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...
CBER director Vinay Prasads departure at the end of next month raises questions across the biotechnology sector about how the agencys approach to vacc...
Former FDA official Grail Sipes says questions are emerging about the long-term impact of the Commissioners National Priority Voucher program, warning...
Insulet initiates a Class 1 device correction for certain lots of its Omnipod 5 Automated Insulin Delivery System pods after identifying a manufacturi...
FDA approves Novartis Cosentyx (secukinumab) for treating adolescents aged 12 and older with moderate to severe Hidradenitis Suppurativa.
