FDA posts a draft guidance outlining methods drugmakers should use to collect long-term safety and efficacy data once cell and gene therapy products a...
FDA warns San Juan, Puerto Rico-based Cellebration LLC that it is violating the Federal Food, Drug, and Cosmetic Act and agency regulations by refusin...
Acadia Pharmaceuticals says it will cease developing intranasal carbetocin after its Phase 3 COMPASS PWS trial of the drug for treating hyperphagia in...
FDA publishes a draft guidance with recommendations for expedited development and review of regenerative medicine therapies for serious conditions.
FDA publishes a draft guidance on agency requirements and considerations for using various clinical trial designs and endpoints to support licensure o...
Reps. Pfluger and Landsman introduce bipartisan legislation to deem biosimilars to be interchangeable upon FDA approval.
uniQure reports favorable data on its investigational gene therapy AMT-130 in Huntingtons disease patients.
FDA warns Janssen Vaccines about CGMP violations in its Incheon, South Korea, drug manufacturing facility.
