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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As its acquisition by Takeda Pharmaceutical edges closer and closer, Shire reported a solid second-quarter.
Only a matter of days after Roche filed its second-quarter financial report, it’s had plenty of news to report.
The U.S. Food and Drug Administration (FDA) approved New York-based Progenics Pharmaceuticals’ New Drug Application (NDA) for Azedra for adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy. It is the first and only therapy approved for these indications.
The U.S. Food and Drug Administration (FDA) approved Indivior’s Perseris for schizophrenia.
Bristol-Myers Squibb reported a strong second quarter, with total revenues of $5.7 billion, up 11 percent from the same quarter in 2017, when it reported $5.144 billion. Sales were driven by Eliquis (apixaban) and Opdivo (nivolumab).
Shares of AbbVie are up slightly this morning after the company announced that it finally received regulatory approval for its endometriosis drug elagolix. The approval marks the first new approved oral treatment for endometriosis-associated pain in more than 10 years.
GlaxoSmithKline continues to make headway in the development of two-drug regimens to benefit HIV patients – even those who have high levels of the virus.
Shares of Eli Lilly jumped in premarket trading after the company reported total revenue of $6.35 billion for the second quarter, a 9 percent increase in revenue over the same period last year.
Shares of Agios Pharmaceuticals jumped this morning after the company said the FDA approved its oral leukemia treatment Tibsovo (ivosidenib). It’s the second approval for the company in less than a year.
The U.S. Food and Drug Administration is looking to address supply chain threats by potentially importing foreign drugs under a narrow scope.