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Cancer Review Pathway Research & Development

First US FDA RMAT Designation Of 2019 Goes To ExCellThera’s ECT-001

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Executive Summary

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: New Claims For Tukysa, Brukinsa; US FDA Wants More Patients To Support Donanemab, Pediatric Airsupra Bids

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

FDA’s Novel Approvals Again Led By Oncology And Neurology, But Dermatology Also Shone In 2022

Pink Sheet infographic breaks down the trends and surprises in 2022 approvals. Cancer therapies and non-malignant hematology exceeded the average use of expedited review programs but were weighted to orphan diseases, while dermatology saw first-in-class approvals for big markets.

Keeping Track: A Blizzard Of Submissions At The US FDA

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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