First US FDA RMAT Designation Of 2019 Goes To ExCellThera’s ECT-001
Five-month drought broken by ExCellThera’s "optimized culture system" designation for treatment of hematologic malignancies. The Pink Sheet details each of the 27 announced Regenerative Medicine Advanced Therapy designations in a table.
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Keeping Track: Lilly’s Mounjaro Enters Diabetes Market; Biogen/Eisai Lecanemab Leads Neuroscience News
CDER turned in its 13th novel approval of 2022 on Friday the 13th, and other drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Real-world evidence – and maybe even an opioid-sparing claim – will be part of Pfizer’s efforts to grow the CGRP space if its $11.6bn bid for Biohaven’s migraine assets goes through. Nurtec ODT (rimegepant) is the star, but pending fast-acting zavegepant could play a valuable supporting role.
Keeping Track: AZ’s Busy Oncology Biz, Phathom’s Voquezna Approval, And A Trio Of Complete Response Letters
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker