FDA
While the FDA did not announce the recipient names of the Commissioner’s National Priority Vouchers, the agency’s descriptions of the awarded products match those in development at Compass Pathways, Transcend Therapeutics and Usona Institute.
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After Replimune’s advanced melanoma drug was rejected for a second time, CEO Sushil Patel slammed the FDA for failing to exercise regulatory flexibility, while other experts bemoaned the agency’s lack of consistency. With new safety guidelines for gene editing therapies, the FDA has taken a first step toward fixing both problems.
BioSpace looks back at 2025 and where the FDA is going in 2026.
The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.
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In looking at companies that are shaping the future, Time Magazine selected 50 business that are leading the charge. While many tech companies lead the way, there are several pharma and life science companies that are also disrupting the future.
The U.S. Food and Drug Administration gave Akcea Therapeutics and its parent company Ionis Pharmaceuticals the green light for Tegsedi, its treatment for polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
Genentech snagged a new regulatory approval for its hemophilia treatment, Hemlibra. On Thursday the U.S. Food and Drug Administration approved the medication for hemophilia A patients who do not have factor VIII inhibitors.
Eisai Co., Ltd. announced today that its U.S. subsidiary Eisai Inc. received approval from the U.S. Food and Drug Administration (FDA) for an indication expansion for Eisai’s antiepileptic drug (AED) Fycompa (perampanel)
It looks to be a pretty busy week for the U.S. Food and Drug Administration (FDA), with a number of target action dates for various drugs. Some were delayed, and some were already approved, but there are still a number on the schedule. Here’s a look.
The U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company’s Emgality (galcanezumab-gnlm) for migraine prevention.
The U.S. Food and Drug Administration approved Pfizer’s once-per-day oral medication Vizimpro, a first-line treatment for patients with a rare form of lung cancer, the company announced late Thursday.
The DEA has reclassified GW Pharmaceutical’s cannabidiol epilepsy treatment Epidiolex as a Schedule V product, which will clear the way for commercialization within the next six weeks.
Shares of Verastem closed out Monday trading on a positive note and continues to climb in the premarket following the greenlight for leukemia drug Copiktra, an inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma.
The U.S. Food and Drug Administration (FDA) has a few target action dates scheduled for this week, including one for Sunday, September 23, which was approved in late August.