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Cell/Gene Tx channel feed
FDA widens Sarepta’s Duchenne gene therapy label to older boys in significant expansion of use
Last year
Pharma
FDA+
International society criticizes Utah law for permitting unapproved stem cell therapies
Last year
Pharma
FDA+
FDA loosens side effect reporting requirements for some CAR-T therapies
Last year
Pharma
FDA+
Updated: Taysha teases early gene therapy data for Rett syndrome
Last year
R&D
Autoimmune CAR-T data dump: Kyverna, Cabaletta shares fall after unveiling early-stage results
Last year
R&D
Ultragenyx to seek accelerated approval for rare disease gene therapy
Last year
FDA+
Pfizer’s Duchenne muscular dystrophy gene therapy fails Phase 3 trial
Last year
R&D
BioNTech co-founder Özlem Türeci on ‘hip’ ADCs and the power of combo therapies
Last year
People
R&D
Updated: What the first five participants for FDA's Operation Warp Speed for rare diseases are tackling
Last year
FDA+
Intellia plots Phase 3 study and a 2026 FDA submission after CRISPR therapy cuts swelling attacks by 98%
Last year
R&D
Iovance's TIL therapy plus Keytruda show durable treatment effect in melanoma, but access remains a question
Last year
R&D
Adaptimmune taps Galapagos to decentralize manufacturing of solid tumor T cell therapy
Last year
Deals
Manufacturing
Ultragenyx touts Phase 3 win for gene therapy in rare glycogen storage disorder
Last year
R&D
Bristol Myers' CAR-T therapy Breyanzi adds new approval in mantle cell lymphoma
Last year
Pharma
FDA+
Flush with cash, Novo Nordisk Foundation now plans to reinvest some GLP-1 profits into regenerative medicines
Last year
R&D
Ori Biotech, Cytiva separately unveil tech to accelerate cell therapy production
Last year
Manufacturing
New York startup raises $33M for fertility treatment based on George Church’s stem cell research
Last year
Financing
FDA details new 'platform technology' process that could accelerate cell and gene therapy approvals
Last year
FDA+
Second engineered B cell therapy enters the clinic, promising to do in hemophilia B what gene therapies can't
Last year
R&D
FDA+
ReNAgade is acquired by RNA rival a year after megaround-backed launch
Last year
Deals
Merck KGaA makes $600M bet to boost manufacturing for viral vectors
Last year
Deals
Manufacturing
FDA's Marks, Woodcock talk regulatory flexibility for new rare disease drugs
Last year
FDA+
Evotec ends gene therapy business, shuts down facility in Austria
Last year
Pharma
Manufacturing
Bristol Myers' CAR-T therapy Breyanzi adds follicular lymphoma to list of approvals
Last year
Pharma
FDA+
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