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After debuting on the public markets with $256.3 million and raking in an additional $472 million, Veradermics has emerged as one of biotech’s biggest post-IPO standouts. CEO Reid Waldman credits the weight loss craze for establishing consumer-driven channels.
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Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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Tuesday, the FDA approved Qalsody—formerly tofersen—on a conditional basis to treat SOD1-ALS.
For those looking to transition out of academia, moving into a government role could be one of the most rewarding pathways available.
Govorestat failed its primary composite measure but showed signals of efficacy, leading the company to push forward with an NDA.
The partial clinical hold follows Foghorn’s voluntary pause of the study and is due to one patient developing irregular heartbeat following treatment with FHD-609.
Eplontersen halted ATTRv-PN disease progression and improved quality of life through 66 weeks. The drug has a PDUFA date of Dec. 22, 2023.
To give the FDA more time to evaluate updates to quizartinib’s proposed REMS program, the regulator is pushing the target action date to July 24.
Friday, the Supreme Court granted the FDA’s application for a stay, effectively maintaining access to the abortion pill mifepristone as its case goes through the appeals process.
The FDA’s Center for Biologics Evaluation and Research is aiming to recreate the success achieved with the rapid development of COVID-19 vaccines under a program of the same name.
This week, the FDA will release its verdict on Biogen and Ionis’ ALS candidate tofersen and three other investigational medicines for psychiatric disorders, hormonal insufficiency and gut infection.
AbbVie shared more positive results for its migraine prevention drug, Qulipta, just three days after FDA approval to expand its label.