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FDA
Pfizer will go toe-to-toe with CSL Behring following the FDA’s Friday approval of its hemophilia B gene therapy Beqvez and will launch a warranty program based on the durability of response.
FEATURED STORIES
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.
Job Trends
Gilead Sciences Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on studies evaluating the combination of magrolimab plus azacitidine.
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Read our takes on the biggest stories happening in the industry.
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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A new report by the U.S. Government Accountability Office finds that despite the promise of regenerative medicine technologies they are held back by regulatory and manufacturing challenges.
In a Phase I trial, Caribou’s allogeneic CAR-T cell therapy candidate induced high rates of treatment response in patients with relapsed or refractory B cell non-Hodgkin lymphoma.
After beginning July with a splash in the Alzheimer’s space, the FDA is expected to make three decisions during the next two weeks; two for cancer and one for a viral skin disease.
For over three years, no interest has accrued on federal student loans and no payments were required. Soon, mandatory payments will resume, leaving workers with less money in the bank.
Recent data from the Phase III study of donanemab emphasize a correlation between amyloid and tau. Experts say a greater understanding of this link could further Alzheimer’s drug development.
FDA
The regulator on Thursday approved Opill, the first oral contraceptive available in the U.S. without a prescription. Perrigo shares rose 6% in response to the news.
Data from the OCARINA II trial shows that a 10-minute subcutaneous injection of Ocrevus achieves similar pharmacokinetics as the typical hours-long intravenous infusion in multiple sclerosis patients.
Following its initial lawsuit last month, Merck has now requested that a federal judge rule on its Inflation Reduction Act case against the Biden administration without a trial.
As the market recovers from the effects of the COVID-19 pandemic, employers are beginning to regain some of the power they lost in recruiting, forcing candidates to adjust their asks.
The tech giant is investing $50 million in the Utah-based biotech to accelerate development of its AI foundation models for drug discovery.