FDA Performance Tracker
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Keeping Track: Return & Renewal At US FDA
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.
Keeping Track: Rybrevant Goes RTOR, Two-Part Review For Dasiglucagon, And CRL For Ultomiris
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
A Standard September Ahead Thanks To Light US FDA User Fee Calendar With Few Expedited Reviews
Twelve applications with September goal dates include six novel agents but only one breakthrough designation.
A 3-Month Delay For A Better Label: US FDA User Fee Goal Extensions Are Usually Good News
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.
US FDA’s Breakthrough Designation Pace Slows, But Topics Broaden
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.
Keeping Track: First-In-Class Candidates In COPD, Cancer Join US FDA Review Queue
Recent applications for approval also include another DMD therapy, another hemophilia B gene therapy, and a new antibiotic.
US FDA Novel Approvals Total 35 In First Half 2023, Riding Resurgent Biologics Wave
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 Columvi Approval By US FDA Takes Bispecific Antibodies Into Fixed-Duration Therapy
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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