FDA Performance Tracker
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Takeda’s TAK-721 is back, ARS Pharma will be back soon to appeal neffy complete response letter, US FDA’s Project Renewal brings Temodar labeling in current day, and more highlights from the Pink Sheet’s US FDA Performance Tracker.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Twelve applications with September goal dates include six novel agents but only one breakthrough designation.
Pink Sheet analysis finds big jump in the share of novel approvals that received PDUFA extensions, largely driven by clinical and safety data submissions.
Keeping Track: Pfizer And J&J’s Dueling Myeloma Bispecifics; Regeneron And Ipsen Nab Priority Vouchers
Shared REMS, diverse confirmatory trials and manufacturing delays are among the highlights in the latest US FDA drug approval news from the Pink Sheet’s US FDA Performance Tracker.
The 19 breakthrough therapy designations awarded so far this year run the gamut from areas that traditionally have not fared well with BTDs, like cardiovascular and respiratory disease, alongside the traditional cancer and orphan disease tentpoles.
Recent applications for approval also include another DMD therapy, another hemophilia B gene therapy, and a new antibiotic.
US FDA’s drug center clears 26 novel agents, changing course from 2022’s disappointing first half, while the biologics center’s smashed two decades of records with nine novel approvals in six months.
Roche’s second CD20xCD3 bispecific antibody approval in six months is the first bispecific with a 2:1 structural format as well as the first dosing regimen with a fixed time period.
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