Latest Biotech News

Bristol Myers Squibb won accelerated FDA approval for Zenbexus (iberdomide) in combination with daratumumab, hyaluronidase-fihj, and dexamethasone for advanced multiple myeloma after at least one...

Cretostimogene grenadenorepvec delivered durable efficacy in BCG-unresponsive, non–muscle-invasive bladder cancer, with Phase 3 BOND-003 Cohort C results in The Lancet Oncology showing complete...

Capricor moved to recalibrate its Duchenne muscular dystrophy regulatory strategy after an FDA advisory committee setback, saying it will ask for review of additional data and analyses. The...

ICER said AstraZeneca’s new blood pressure medicine Baxfendy is not cost-effective at its list price of $10,950 per year, highlighting a value-versus-price debate that is likely to influence payer...

Proteotype Diagnostics said it is initiating a new clinical study for Enlighten, its multicancer early detection test, to support a CE-IVDR submission, as it accelerates toward commercialization....

Leerink initiated coverage of Freenome with an Outperform rating and an $18 price target, citing the company’s role as an R&D engine in liquid biopsy cancer screening. The bank pointed to expected...

Fujifilm Biotechnologies highlighted recent expansion momentum in U.S. and European operations, including FDA selection of a Holly Springs, North Carolina commercial cell culture facility for the...

Aligned Marketplace secured $20 million in a Series A to expand its advanced primary care marketplace, following a total funding figure of $31 million to date. Venrock led the round, reinforcing...

Boulevard emerged from stealth with about $65 million in launch financing to build B cell–directed therapies, supported entirely by Deerfield Management and its internal discovery engine, 3DC. The...

Quantum-Si said it is laying off about 20% of its workforce and pushing the Proteus protein sequencing system launch to Q2 2027. The proteomics company previously targeted early-access...

The FDA granted accelerated approval to Bristol Myers Squibb’s Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj, plus dexamethasone, for adults with advanced multiple...

Capricor pivoted after an FDA advisory committee setback, saying it will seek approval using an amended Duchenne muscular dystrophy (DMD) submission that incorporates additional data and analyses....

PTC Therapeutics won a $211 million bankruptcy auction for Sangamo’s ST-920 (isaralgagene civaparvovec), a one-time AAV gene therapy candidate for Fabry disease. The winning bid includes $111...

Immunobiota Therapeutics advanced its oral immune tolerance strategy for type 1 diabetes with IBT-100, a non-immunosuppressive metabolite-based therapy designed to deliver disease modification...

Proteotype Diagnostics is launching a new 7-year clinical study for Enlighten, its multicancer early detection (MCED) blood test, with plans to support CE-IVDR submission. The company also set...

Boulevard emerged from stealth with approximately $65 million in launch financing to develop B cell-directed multi-specific antibody therapies, backed entirely by Deerfield Management. The...

Thermo Fisher completed an Olink Explore HT proteomic run on roughly 5,500 research samples from the Michael J. Fox Foundation’s PPMI cohort, and deposited the resulting dataset into PPMI’s...

Illumina secured a $1 billion credit facility with Bank of America and also entered an underwriting agreement for a $300 million note offering. The credit arrangement replaces an older facility...

Quantum-Si laid off about 20% of its workforce as it pushed the Proteus protein sequencing system launch to Q2 2027. The proteomics company said the timing shift supports an additional integrated...

OraSure Technologies withdrew its FDA 510(k) and CLIA waiver submission for its InteliQuick CT/NG point-of-care molecular test after discussions with the agency. The company disclosed the move...