Latest Biotech News

FDA leadership for cell and gene therapy oversight is in transition. Acting director of the Center for Biologics Evaluation and Research’ Office of Therapeutic Products Vijay Kumar is stepping...

The U.S. Department of Health and Human Services has announced that COVID-19 Emergency Use Authorization declarations for certain medical devices will end in 180 days. HHS said the determinations...

The FDA’s PreCheck pilot is expanding its regulatory manufacturing workflow. The agency cleared the first flight of the program’s manufacturing pilot through seven biopharma companies, aiming to...

Thermo Fisher’s antibody validation image controversy escalated as researchers criticized not only the underlying images but also the company’s response and remediation approach. The issue...

AbbVie and Genmab reported a Phase 3 combination success for Epkinly (epcoritamab) with lenalidomide in diffuse large B-cell lymphoma. The Epcore DLBCL-4 trial met its primary endpoint by reducing...

Beeline Medicines secured a further $126.3 million in funding for its immune-mediated disease pipeline, adding to an already large Series A total. The extension was led by existing supporters and...

FDA granted an investigational device exemption for Adaptive Biotechnologies’ ClonoSeq MRD assay in a clinical trial sponsored by Imviva Biotech. The IDE covers use of ClonoSeq for TENACITY-01, an...

Sanofi reported a positive Phase 3 outcome for Lumizyme’s successor in infants with severe Pompe disease, supporting a potential U.S. label expansion. The company said its enzyme replacement...

Ipsen agreed to buy Kartos Therapeutics for $450 million upfront as it builds out late-stage blood cancer exposure through navtemadlin, an investigational oral MDM2 inhibitor. The acquisition is...

Two innovation signals pointed toward scaling translational biology infrastructure. First, Geneseeq’s Fragmentia-AI platform introduced a computational approach to fragmentomic cell-free DNA...

FDA’s acting director of cell and gene therapies Vijay Kumar is stepping down from his role overseeing CBER’s Office of Therapeutic Products, according to statements reported by Endpoints News and...

The FDA launched and expanded its PreCheck Pilot Program for manufacturing plants, selecting companies including Eli Lilly, Regeneron, Cellares, and Fujifilm to participate. The program is...

Abivax provided additional data for its ulcerative colitis drug obefazimod, aiming to address cancer safety concerns that had rattled investors earlier in June. The company said the updated safety...

The New England Journal of Medicine retracted a pivotal phase 3 article for Amgen’s Tavneos (avacopan) after academic authors reported that primary endpoint assessments in nine patients were...

Imviva Biotech received an FDA investigational device exemption (IDE) to use Adaptive Bio-Technologies’ ClonoSeq MRD assay in its TENACITY-01 Phase Ib/II trial of CTD402, an allogeneic anti-CD7...

Ipsen agreed to acquire Kartos Therapeutics for $450 million upfront, with potential milestones up to $1.3 billion, securing navtemadlin—an oral MDM2 inhibitor aimed at restoring p53 function....

Bristol Myers Squibb spinout Beeline Medicines raised an additional $126.3 million through a Series A extension, bringing total capital to $426.3 million. The funding supports scaling its immune...

AbbVie and Genmab reported positive Phase 3 results for Epkinly (elacestrant?) in combination with lenalidomide in diffuse large B-cell lymphoma, with the Epcore DLBCL-4 trial meeting its primary...

Aveta Biomics selected Natera’s Signatera ctDNA assay to measure minimal residual disease in its Phase 3 trial of APG-157, an oral immunotherapy program targeting locally advanced head and neck...

Roche launched its Axelios 1 next-generation sequencing platform to compete directly with Illumina’s installed base, aiming to address bottlenecks around accuracy, speed, flexibility, scalability,...