Keeping Track: Viltepso Earns Priority Review Voucher; Manufacturing Trips Fennec; Eagle Drops Ryanodex Exertional Heat Stroke Bid
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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After successive CRLs in 2020 and 2021, the drug gained a broad label for hearing loss in children treated with cisplatin for localized, non-metastatic solid tumors.
Keeping Track: US FDA Approves Amgen’s Lumakras, Myovant’s Myfembree; New Claims For Biohaven’s Nurtec, BMS’ Zeposia
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Durable responses have continued to be seen two years after administration of Sarepta’s candidate gene therapy to four boys with Duchenne muscular dystrophy.