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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
A rapturous response to data published last year for Pelage’s hair loss candidate overwhelmed the biotech. Now, the company is ready to show the world the science behind the breakthrough.
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Novo Nordisk and Eli Lilly have been battling head-to-head in an exploding obesity market. They should never have been compared apples to apples.
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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.
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.
This is the first round in a series of cuts that will cost 75 people their jobs this year, according to a WARN notice. Employees in other states are affected as well.