A regulatory consulting firm's report finds that FDA sharply increased enforcement activity against drugmakers and distributors in fiscal year 2025, i...
CBER director Vinay Prasads departure at the end of next month raises questions across the biotechnology sector about how the agencys approach to vacc...
A legal update from ArentFox highlight several emerging regulatory and enforcement developments at FDA thatare expected to have significant implicatio...
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.
FDA expands the approved use of GSKs Arexvy, a respiratory syncytial virus accine that now includes the in adults aged 18 to 49 who are at increased r...
Eli Lilly issues a public warning that its testing found that compounded tirzepatide with vitamin B12 can produce an unknown impurity from a chemical ...
