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FDA Performance Tracker

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US FDA’s June Approvals Forecast: Nearly 30 Goal Dates Suggest Hot Start To Summer

June goal dates include RSV and pneumococcal vaccines, two COPD therapies, Rocket and Sarepta gene therapies, and lots of oncology.

US FDA Performance Tracker Drug Review

US FDA’s Novel Approvals Peak Near Year-End, Analysis Of Last Decade Suggests

The Center for Drug Evaluation and Research’s novel approvals concentrated in August, November, and December, while January and June were the slowest months, according to a Pink Sheet analysis of 2014-2023 data.

Approvals US FDA Performance Tracker

Keeping Track Of AdComms: US FDA Puts Donanemab On Schedule, Delays COVID-19 Meeting

Newly announced US FDA advisory committee meetings on Lilly’s Alzheimer’s antibody, Lykos’ pioneering psychedelic therapy for PTSD relieve drought in non-oncology AdComms as the 2024-‘25 COVID vaccine strain selection meeting is postponed.

US FDA Performance Tracker Advisory Committees

US FDA May User Fee Preview: Vaccines, Gene Therapy, And Double Oncologics

Five novel agents are among the user fee goal dates coming up in May 2024.

US FDA Performance Tracker Review Pathway

Keeping Track: Two Breakthrough Oncologics, Another Antibiotic Clear US FDA Along With Pfizer’s Hemophilia B Gene Therapy

The US FDA approved Day One’s pediatric brain cancer drug Ojemda, ImmunityBio’s bladder cancer immunotherapy Anktiva, an uncomplicated UTI claim for Utility Therapeutics’ Pivya, which has a long history in Europe, and Pfizer’s hemophilia B gene therapy Beqvez.

US FDA Performance Tracker Approvals

Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa

The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.

US FDA Performance Tracker Approvals

Abecma Approval In Earlier Myeloma Carries Caution On Early Death Data

Labeling describes early death imbalance that delayed approval of Bristol Myers Squibb’s CAR-T therapy for more than three months after its user fee goal, but does not add to boxed warning; J&J’s Carvykti is due for imminent US FDA action on its own early-stage myeloma bid.

US FDA Performance Tracker Drug Safety

Keeping Track: Cardio-Renal Drugs At Heart Of US FDA’s March Approval Binge

Seven novel agents approved in March include one accelerated approval, two rare pediatric disease priority review vouchers, two breakthrough therapy designations and one regenerative medicine advance therapy designation.

US FDA Performance Tracker Approvals

PTC’s Upstaza Takes Gene Therapy Straight To Brain (And US FDA); Translarna To Return Mid-Year

In a year full of regulatory milestones for the firm, PTC Therapeutics hopes to set some approval precedents – and basically hopes its candidates have an easier time of it than they have had before.

US FDA Performance Tracker Gene Therapy
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