FDA Starts 2015 As It Plans To Go On: A Spate Of Approvals, A Full Slate Of Possibilities
With more than 40 novel agents under FDA review – and six approvals already – prospects are good for 2015 to be another stellar year for new molecular entity and novel biologic approvals. Supplemental indications with “breakthrough” designations and the first biosimilars could challenge the primacy of NMEs in the approval narrative.
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After an impressive commercial run for Biogen Idec, with four drug launches in two years, it’s up to R&D to deliver more innovative medicines. The bar is high in the areas of neurology Biogen is exploring; Chief Medical Officer Alfred Sandrock discussed the company’s R&D momentum in a recent interview.
Keeping Track: US FDA Clears Santen’s Omlonti, Fennec’s Pedmark; Lilly’s Retevmo Adds Tumor-Agnostic Claim
The latest drug approval news and highlights from the Pink Sheet’s US FDA Performance Tracker