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The FDA on Friday approved GSK’s application to use Arexvy to vaccinate adults aged 50 to 59 years who are at increased risk of developing severe respiratory syncytial virus.
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Nearly 90% of senior leaders who were at the FDA a year ago are no longer with the agency, a BioSpace analysis shows. None remain from the Office of the Commissioner.
Early decisions about manufacturing and supply chains could prove costly as a company reaches the commercial stage.
While the TrumpRx deals only cover Lilly and Novo for now, the agreements are good for any cardiometabolic biotechs waiting in the wings, according to a new 2026 preview report from PitchBook.
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Moderna, Inc. today announced positive interim data from the Phase 2/3 KidCOVE study of the Moderna COVID-19 vaccine (mRNA-1273) in children 6 months to under 2 years and 2 years to under 6 years of age.
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After covering the Alzheimer’s space through every high and low, BioSpace’s Annalee Armstrong welcomes back Roche for the 2026 Alzheimer’s Renaissance.
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Despite a sharp downturn in initial public offering activity, New York-based gene therapy company Lexeo Therapeutics and French biotech Abivax are seeking funding for their lead candidate programs.
An FDA advisory committee this week voted overwhelmingly against BrainStorm Cell Therapeutics’ amyotrophic lateral sclerosis treatment. However, other potential therapies offer hope for ALS patients.
Thursday’s approval comes after the FDA pushed back the target action dates for Amicus’ Biologics License Application in May, allowing the regulator more time to review the company’s submitted data.
The biopharma is projecting its HIV business will reach up to $8.5 billion in sales by 2026, based on the success of its long-acting antiretroviral therapy Cabenuva.
Following disappointing results in a mid-stage social anxiety disorder study, the Australian biotech’s investigational ion channel modulator demonstrated promising effects in patients with post-traumatic stress disorder.
After several rejections over 20-plus years, Fabre-Kramer Pharmaceuticals has secured the FDA’s approval for its major depressive disorder drug gepirone hydrochloride, now marketed under the brand name Exxua.
After a groundbreaking year in the Alzheimer’s space, Parkinson’s disease researchers express renewed hope based on a greater biological understanding of neurodegeneration.
The FDA will kick off October with an advisory committee meeting for Amgen’s Lumakras and target action dates for Alnylam’s patisiran and Bristol Myers Squibb’s Opdivo.
If approved by the FDA, Karuna Therapeutics’ investigational agonist of muscarinic acetylcholine 1 receptors M1 and M4 would provide the first new mechanism of action for schizophrenia patients in decades.
The companies, which have been partners for a decade on various research programs, are pooling their efforts in two early-stage programs for Alzheimer’s and Huntington’s diseases using RNA-targeting medicines.