Federal Register notice: FDA announces an 11/18 joint advisory committee meeting to discuss a Laboratoire HRA Pharma supplemental NDA for Opill (norge...
Federal Register notice: FDA finalizes a list of alternative or streamlined mechanisms for complying with GMP requirements for combination products.
FDA publishes a draft guidance entitled Computer Software Assurance for Production and Quality System Software that the agency says offers a risk-base...
FDA approves a Bristol Myers Squibb NDA for plaque psoriasis drug Sotyktu (deucravacitinib), a first-in-class, oral, selective, allosteric tyrosine ki...
BioMarin Pharmaceutical tells FDA a patient participating in the companys hemophilia A Phase 3 gene therapy trial of valoctocogene roxaparvovec (BMN 2...
Federal Register notice: FDA makes available a draft guidance entitled Statement of Identity and Strength Content and Format of Labeling for Human No...
Teva urges the U.S. Supreme Court to dismiss a GlaxoSmithKline argument that the high court should not hear Tevas appeal of a skinny label case involv...
FDA clears a Boston Imaging 510(k) for its V7, an ultrasound system said to enhance image clarity.
