FDA medical reviewers tell the Endocrinologic and Metabolic Drugs Advisory Committee that they believe the Intarcia NDA for its ITCA 650 drug/device c...
Two attorneys say their review of drug preemption cases shows that the defense is demanding but can be attained.
FDA grants Disc Medicine a fast-track designation for MWTX-003 and its use for treating patients with polycythemia vera.
Relmada Therapeutics says a Phase 3 trial in Major Depressive Disorder shows that patients treated daily with REL-1017 for up to one year experienced ...
Taysha Gene Therapies says it is discontinuing the development of its gene therapy TSHA-120 program as a treatment for giant axonal neuropathy after r...
UCB says its BLA for plaque psoriasis drug bimekizumab is facing another FDA review extension.
Federal Register notice: FDAs Office of Womens Health and Office of Clinical Pharmacology announces a 10/11 public workshop: Menopause: Potential Impa...
Medline Industries recalls its Hudson RCI Addipak unit dose vial, 0.9% full normal saline solution (Lot 3B085) due to sterility concerns.
