Keeping Track: US FDA Clears Opioid Seglentis And Anti-Opioid Zimhi; CRLs For Revance, United; Delay For UCB
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
You may also be interested in...
The company is preparing a staged launch for the neuromodulator in the aesthetics market, with a focus on educating select dermatologists first before expanding to 4,000 physician partners.
Avadel challenges FDA requirement that it submit patent certification, asks court to direct the agency to issue final approval of its narcolepsy drug Lymryz. Having often criticized the use of REMS to delay competition, FDA now finds itself defending an Orange Book listing.
Keeping Track: Jardiance Approved Across Heart Failure Spectrum, But US FDA Turns Down Bardoxolone, Terlipressin
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.