AbbVie files a supplemental NDA for venetoclax in combination with a hypomethylating agent or in combination with low-dose cytarabine for treating new...
BioElectronics files a 510(k) for ActiPatch and its over-the-counter adjunctive use in treating musculoskeletal pain.
Federal Register notice: FDA makes available a draft guidance entitled Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry.
FDA releases three new and three updated guidances to help sponsors developed gene therapy products, including for specific diseases.
Federal Register notice: FDA seeks comments on an information collection extension for its Guidance on Formal Meetings With Sponsors and Applicants fo...
Federal Register notice: FDA makes available a draft guidance entitled Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Preventio...
CDERs Office of Prescription Drug Promotion says an Arog exhibit booth and Web page are promoting its investigational unapproved new drug Crenolanib.
FDA approves a Medtronic PMA for a less-invasive implant approach for its HVAD System, a left ventricular assist device for patients with advanced hea...