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The FDA approved Bristol Myers Squibb’s Breyanzi for chronic lymphocytic leukemia and small lymphocytic leukemia prior to Friday’s adcomm for the company’s other CAR-T therapy, Abecma.
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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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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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The FDA has approved the combination regimen of Merck’s Keytruda and Seagen and Astellas’ Padcev for the first-line treatment of locally advanced or metastatic urothelial carcinoma.
With data from the Phase III trial of donanemab expected in Q2, Eli Lilly presented the first clinical results from its next anti-amyloid antibody, remternetug, at AD/PD 2023.
In a potential leap forward for sickle cell disease, Vertex moved closer to launching its one-time treatment for sickle cell disease and transfusion-dependent beta-thalassemia.
BioNTech will pay Shanghai-based Duality Biologics $170 million upfront for rights to two of its topoisomerase-1 inhibitor-based antibody drug conjugates.
Almost two years after its launch, eye-focused gene therapy start-up Vedere Bio II is closing its doors, company leaders announced through a LinkedIn post over the weekend.
Cytokinetics is discontinuing the Phase III COURAGE-ALS trial in amyotrophic lateral sclerosis after its candidate reldesemtiv failed a planned interim analysis, the company announced Friday.
HUTCHMED has completed the rolling submission of its New Drug Application to the FDA for fruquintinib, its candidate for refractor metastatic colorectal cancer.
With several recent milestones, Intellia Therapeutics is setting a solid foundation for gene editing in rare diseases with an eye toward broader patient populations.
Ravi B. Parikh discussed how new FDA guidance on accelerated approval for cancer drugs will affect the space.
Nearly eight months after leaving his post as head of R&D at Johnson & Johnson, Mathai Mammen has found a new job as CEO of cancer focused FogPharma.