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FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), an anti-PD-1 therapy for treating patients ...[ Price : $8.95]
FDA clears a BrightWater Medical 510(k) for the ConvertX Nephroureteral Stent System for treating ureteral obstructions, which pre...[ Price : $8.95]
FDA updates six REMS, including approval of a REMS for Novo Nordisks Xultophy.[ Price : $8.95]
Two Project on Government Oversight reports call for an end to user fees that the group says make FDA too financially dependent on...[ Price : $8.95]
Egalet Corp. files a supplemental NDA for Oxaydo (oxycodone HCl) tablets for an abuse-deterrent label claim for the intravenous ro...[ Price : $8.95]
CDER issues its latest drug standards program quarterly progress report.[ Price : $8.95]
FDA denies two petitions asking it to find that Wyeths original formulation of Protonix IV was not withdrawn for reasons of safety...[ Price : $8.95]
Pfizer says its pivotal REFLECTIONS B3271002 study, a comparative safety and efficacy study of biosimilar candidate PF-05280014 ve...