Keeping Track: Oncology Approvals And Responses To Complete Response Letters
The latest drug development news and highlights from our FDA Performance Tracker.
You may also be interested in...
Newron's Parkinson's Disease Drug Xadago Priced At $600-700/Month
First new chemical entity for Parkinson's to clear FDA in 10 years, Xadago has a narrower indication than Teva's Azilect and similar pricing.
Newron's Parkinson's Drug Xadago Has Narrower Indication Than Teva's Azilect
After overcoming regulatory hurdles, Newron may have tough time competing in US against market stalwart Azilect; eight Parkinson's drugs are in Phase III trials.
‘File Over Protest’ At US FDA: PTC To Pursue Rarely-Used Pathway For DMD Drug
Translarna’s best path forward is the file over protest pathway for the application, which received a refuse to file letter last year, PTC says; former OND Director John Jenkins calls it ‘a fairly rare event.’