FDA cites Ipca Laboratories over multiple manufacturing and quality deficiencies following an inspection of the companys active pharmaceutical ingredi...
A new spending package enacted this week includes two long-sought policy changes for FDA clarifying the scope of orphan drug exclusivity and easing l...
FDA releases the form FDA-483 with seven observations from an inspection at the U.S. Specialty Formulations outsourcing facility in Allentown, PA.
FDA publishes for public comment an International Council for Harmonization draft guideline on patient preference studies involving drug characteristi...
Sangamo Therapeutics begins a rolling BLA submission seeking accelerated approval of its experimental Fabry disease gene therapy, following results fr...
Bayer reports that its investigational oral anticoagulant asundexian reduced the risk of recurrent ischemic stroke by 26% in patients who had recently...
A PDUFA 8 negotiating subgroup reviews industrys counterproposal to FDAs facility lifecycle proposal.
Reuters reports exclusively that the telehealth firm Hims and Hers Health is selling GLP-1 pills for $100 less per month than the branded version offe...
