FDA sends Milestone Pharmaceuticals a complete response letter on its NDA for Cardamyst (etripamil) nasal spray and its use to convert acute episodes ...
The Autism Self-Advocacy Network sharply criticizes HHS for hiring quack David Geier to study a potential link between autism and vaccines, which the ...
A bipartisan group of five Senate Judiciary Committee members introduces legislation to establish an FDA/Patent and Trademark Office task force to imp...
HHS says FDA will lose about 3,500 (18%) of its 19,000 full-time employees under a just-announced reductions in force plan to consolidate activities a...
An exclusive Reuters report says FDA is likely to miss medical device user fee deadlines due to staff shortages from two rounds of cuts mandated by th...
FDA approves a Soleno Therapeutics NDA for Vykat XR (diazoxide choline) extended-release tablets for treating hyperphagia in individuals with Prader-W...
The Department of Justice reaches a settlement in which medical device company Prometheus and its owner agree to pay $550,000 to resolve False Claims ...
FDA accepts a Merck BLA for a subcutaneous formulation of Keytruda (pembrolizumab) for its use across all previously approved solid tumor indications....
