FDA hosts a one-day public workshop 10/23 to explore new approaches for approving patch test allergens used in diagnosing allergic contact dermatitis.
FDA accepts for review a Replimune BLA resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab for treating advanced melanoma i...
Roche reports new favorable data from the Phase 3 evERA Breast Cancer study of its investigational oral therapy giredestrant, used in combination with...
Attorneys at Hyman, Phelps & McNamara say they are encouraged by an FDA draft guidance outlining a roadmap for postapproval monitoring of cell and gen...
The Advanced Medical Technology Association outlines a series of recommendations aimed at strengthening U.S. leadership in medical technology and safe...
Summit Therapeutics reports that its investigational bispecific antibody ivonescimab, when combined with chemotherapy, significantly reduced the risk ...
FDA approves a new indication for Novo Nordisks Rybelsus (oral semaglutide) tablets to reduce the risk of major adverse cardiovascular events in adult...
Kenvue urges FDA to deny a recent citizen petition requesting updates to the pregnancy warning on acetaminophen products.
