Politico reports that FDA commissioner Marty Makary and HHS secretary Robert F. Kennedy, Jr., are feuding over vaccine safety studies and staffing app...
FDA says the Medline 8/22 recall of three models of surgical convenience kits that were not sterilized is Class 1.
FDA approves Regeneron Pharmaceuticals Eylea HD (aflibercept 8 mg) for treating macular edema following retinal vein occlusion.
FDA accepts for review a Nuvalent NDA for zidesamtinib, a next-generation ROS1-selective tyrosine kinase inhibitor being developed for certain adults ...
Two Arnall Golden Gregory attorneys outline highlights in a new FDA question-and-answer guidance on expanded access and suggest ways for industry to u...
Sen. Tom Cotton poses questions for attorney general Pam Bondi about the Justice Departments activities to stop counterfeit drugs and drug ingredients...
Novartis asks FDA to restrict ANDAs or 505(b)(2) NDAs citing the companys Leqvio as the reference-listed drug.
Texas attorney general Ken Paxton reaches a $41.5 million settlement with Pfizer and Tris Pharma after accusing the companies of providing adulterated...
