Imcivree Considered for Expanded Label; Semglee Hits Shelves; Buphenyl for T2D?

The FDA accepted a priority review of a supplemental new drug application for setmelanotide (Imcivree), a melanocortin-4 receptor agonist, for the treatment of Bardet-Biedl syndrome and Alström syndrome, Rhythm Pharmaceuticals announced. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 16, 2022 … After getting the green light from the FDA, Paracrine announced plans to initiate its pivotal ASCEND trial testing its Celution System for diabetic foot ulcers … read more

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