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...
Sun Pharma Advanced Research Company says that Ocuvex Therapeutics has resubmitted an NDA for PDP-716, more than two years after the agency issued a c...
FDA issues a Warning Letter to Cdymax India Pharma Private Limited after inspectors uncovered CGMP violations at the companys active pharmaceutical in...
Merck reports that its drug Winrevair (sotatercept-csrk) significantly improved a key measure of heartlung function in a mid-stage trial of patients w...
