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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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The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.
Approved Thursday via the FDA’s Commissioner’s National Priority Voucher program, Otarmeni is the first gene therapy for hearing loss—and the first treatment to target an underlying cause of the condition.
With a greenlight for ibogaine to enter clinical testing and three unnamed products set to receive Commissioner’s National Priority Vouchers this week, it’s full speed ahead for psychedelics. But will sidestepping normal regulatory protocols actually be a net negative for the field?
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Read our takes on the biggest stories happening in the industry.
Doubling survival in pancreatic cancer, a long-fought rare disease approval, a massive IPO and ambitious biotech entrepreneurs have BioSpace Senior Editor Annalee Armstrong feeling upbeat about the biotech scene.
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The gene therapy world is in turmoil, but Arbor, armed with more than $1 billion in partnerships and raises, is going forward.
Japan-based Taiho Pharmaceutical has worked with Araris Biotech since 2023 developing antibody-drug conjugates for the oncology space.
AstraZeneca has recently been investing heavily in the cell therapy space, including two acquisitions for TeneoTwo and Gracell Biotechnologies.
The appeals court for the Federal Circuit upheld a lower court’s ruling, finding that Regeneron has not sufficiently established that Amgen’s biosimilar Pavblu violates key patents of Eylea.
The company unveiled plans last week to test its GLP-1/glucagon dual receptor agonist in alcohol use disorder and alcohol-related liver disease.
Dyne is eyeing an accelerated approval filing for DYNE-251 in early 2026 that would pit the asset against Sarepta’s Exondys 51 in a patient population amenable to exon 51 skipping.
Having established success in cancer, biopharma is now looking to leverage CAR T therapies against a new target, autoimmune disorders, with several early- to mid-stage readouts expected this year.
Ionis and Ultragenyx are competing to develop oligonucleotide treatments for Angelman syndrome, but will Neuren’s peptide catch up?
As obesity drug developers compete for the highest weight-loss efficacy, experts contend that overall health outcomes—evidenced by successful studies in therapeutic areas like cardiovascular and sleep apnea—may prove a greater market advantage.
The Maryland-based biopharma joins Eli Lilly and Novo Nordisk in trialing a GLP-1 agonist for alcohol- and liver-related conditions.