News

Ralph Abraham, a vocal vaccine skeptic who served at the agency for just three months, has stepped down due to “unforeseen family obligations,” according to the CDC.
FEATURED STORIES
The first gene therapies approved to treat sickle cell disease in December 2023 are struggling on the market. But there are glimpses of forward momentum as Vertex and Genetix Bio provide updates.
After last year’s ‘stampede’ for FGF21 assets, the focus for the metabolic dysfunction-associated steatohepatitis space has shifted toward differentiated approaches, such as THR-β agonists and combination treatments, that seek to mirror the commercial success of Madrigal’s Rezdiffra.
Maintaining America’s momentum demands that policymakers resist policies that undermine research and development incentives.
Job Trends
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
FDA
Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
THE LATEST
Xaira Therapeutics emerged from stealth on Tuesday with plans to tap the biological equivalent of artificial intelligence image generation tools designed to create molecules that hit hard-to-drug targets.
While the San Diego-based biotech awaits a Phase IIa data readout for its lead lung disease candidate, Endeavor BioMedicines’ next-generation HER3-targeted antibody-drug conjugate will start a Phase I/II trial later this year.
A report from the Kaiser Family Foundation estimates that the FDA’s recent approval of Novo Nordisk’s Wegovy to reduce the risk of heart attack and stroke in people with cardiovascular disease will open Medicare coverage to one in four beneficiaries with obesity.
Biogen on Wednesday exceeded analyst profit estimates for the first quarter of 2024 as the biotech’s cost-cutting measures took hold and sales of its Alzheimer’s disease therapy Leqembi started to pick up.
The Celularity CEO and founder tells BioSpace he believes that placenta-derived cells are the future of stem cell therapies to fight autoimmune disease, cancer, even aging.
Despite being hit with a continuing decline in COVID-19 sales and a strong Swiss franc, Roche on Wednesday reported first-quarter sales were up 2% at constant exchange rates.
An undisclosed once-daily oral dose of Neurocrine Biosciences’ Takeda-partnered investigational drug significantly reduced symptom severity in adults with major depressive disorder.
FDA
The FDA on Tuesday approved Day One Biopharmaceuticals’ type II RAF inhibitor Ojemda, which is designed to penetrate the blood-brain barrier, for the treatment of relapsed or refractory pediatric low-grade glioma.
Looking for remote regulatory jobs in the life sciences industry? Check out the BioSpace list of the top five jobs that don’t require relocation.
Despite the benefits of hiring foreign-born STEM employees, some companies avoid it largely due to unfamiliarity with the visa process, according to two recruitment experts.