New Year, New Drugs: Novel Agents With 2014 Action Goals
Almost 50 novel NDAs and BLAs have user fee goal dates for FDA action in the coming year.
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Keeping Track: Oncology Submissions From Blueprint, Y-mAbs, BMS/bluebird; Approvals For BMS’ Reblozyl, LFB’s SevenFact
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.
Sanofi’s next-generation meningococcal vaccine, broader use of Bristol-Myers Squibb’s Reblozyl move toward approval; United Therapeutics foreshadows Trevyent regulatory difficulties.
Wave’s Duchenne muscular dystrophy drug and Lilly’s chronic pain R&D will test the agency’s CID meeting pilot program, while FDA issues draft guidance that highlights potential uses for complex innovative trial designs.