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Latest From Bridget Silverman
US FDA received several applications for new molecular entities last week, including a BLA for Alphaeon's Botulinum toxin that came just three years after number trails began.
Keeping track of US FDA approvals last week included watching the creative and the familiar.
The latest drug development news and highlights from our US FDA Performance Tracker.
US FDA's popular breakthrough therapy designation given to Proteon's vonapanitase for dialysis patients, Synthetic Biologics' ribaxamase to prevent C. difficile infection, and River Vision's teprotumumab for thyroid eye disease; Vericel's cell therapy for heart failure is designated a regenerative medicine advanced therapy.
Echoing complaints of other recent complete response recipients, TherapeuticsMD charges that US FDA's request for 12-month safety data for the dyspareunia therapy TX004HR is not consistent with earlier communications with agency.
Keeping Track: Neurology And Breakthroughs Stay In Spotlight As US FDA Approves Radicava, Imfinzi; TaiMed Submits Ibalizumab
The latest drug development news and highlights from our Performance Tracker.