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First-in-class CELMoD myeloma approval in the US
Bristol Myers Squibb won an FDA accelerated approval for Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-dexamethasone for advanced multiple myeloma, marking the debut of a...
Capricor looks for FDA reconsideration after DMD setback
Capricor Therapeutics is pressing for a regulatory path forward for deramiocel after an FDA advisory committee setback in Duchenne muscular dystrophy. The company says it will seek an FDA review...
M&A and licensing: PTC wins Sangamo’s Fabry gene therapy
PTC Therapeutics won rights to Sangamo’s Fabry gene therapy program ST-920 (isaralgagene civaparvovec) in a competitive bankruptcy auction, outbidding Astellas and TerSera Therapeutics. The...
Manufacturing scale-up and capacity commitments in biopharma
Fujifilm Biotechnologies expanded its US biomanufacturing footprint in Holly Springs, North Carolina, aligning with FDA’s PreCheck Pilot Program selection for commercial-scale cell culture...
Multiple myeloma manufacturing and platform collaboration push
Bristol Myers Squibb selected Houston for a new $2.3 billion multi-modal manufacturing campus designed to cover drug product and finished goods manufacturing from late development through launch....
Regulatory pathway clarity for rare disease: Polaryx Q&A
Polaryx Therapeutics’ clinical development and regulatory affairs vice president outlined how FDA engagement is evolving in rare pediatric lysosomal storage disorders. In an interview, Minsu Kang...
Contract research and manufacturing: FDA withdrawal delays OraSure CT/NG test
OraSure Technologies withdrew its FDA submission and CLIA waiver request for the InteliQuick CT/NG point-of-care molecular test after discussions with the agency. The decision removes the timing...
Oncology translational platform: open organoid dependency biobank
Maos Cancer Cell Dependencies reported a new, publicly available tumor organoid biobank spanning 256 clinically annotated models across colorectal, esophageal, ovarian, pancreatic, and gastric...
Anticancer approach: DUSP4 boosts CD8 CAR-T activity in vivo
Preclinical research reported that DUSP4 can enhance antitumor CD8+ T-cell function and improve CAR-T efficacy in colorectal cancer mouse models. The study frames DUSP4 as a target for...
Diagnostics and commercialization: Proteotype prepares new CE-IVDR support study
Proteotype Diagnostics initiated new clinical work to support CE-IVDR submission for Enlighten, its multicancer early detection (MCED) blood test. The company also planned an additional study to...
Multiple myeloma regulatory approval
Bristol Myers Squibb won FDA accelerated approval for Zenbexus (iberdomide) in combination with daratumumab, hyaluronidase-fihj, and dexamethasone for adults with advanced multiple myeloma. The...
Duchenne muscular dystrophy regulatory path
Capricor moved to re-position deramiocel after prior setbacks with the FDA, announcing plans to amend its BLA to target improved limb function in Duchenne muscular dystrophy. The company said it...
Cell therapy resurgence via open-label FDA-cleared data
Capricor’s deramiocel gained a fresh investor tailwind after the company reported additional open-label extension results tied to Duchenne muscular dystrophy cardiomyopathy. The update followed an...
Multiple myeloma: manufacturing and AI discovery collaboration
Bristol Myers Squibb selected Houston for a new $2.3 billion multi-modal manufacturing campus to produce drug product and finished goods from late development through commercial launch. The plan...
Gene therapy deal: Sangamo Fabry asset sold via auction
PTC Therapeutics won a competitive auction to acquire Sangamo’s Fabry gene therapy program ST-920 (isaralgagene civaparvovec). Under the terms reported, Sangamo will receive $111 million upfront...
Diagnostics regulation: OraSure withdraws FDA submission
OraSure Technologies withdrew its FDA 510(k) and CLIA waiver submission for the InteliQuick CT/NG point-of-care molecular test after discussions with the agency. The move pushes the company’s...
Early cancer detection: Proteotype study to support CE-IVDR filing
Proteotype Diagnostics initiated a new clinical study program for Enlighten, its multicancer early detection blood test, intended to support a CE-IVDR submission in Europe. The Cambridge, UK-based...
Company funding and pipeline build: Boulevard emerges from stealth
Boulevard Bio exited stealth with about $65 million in launch financing to pursue B cell-directed multi-specific antibodies for chronic autoimmune disease. Backed entirely by Deerfield Management,...
Biotech reorganization: BioCryst shifts to external innovation
BioCryst outlined a strategy reset after scrapping its internal discovery programs, signaling that future pipeline additions will come primarily through licensing and external deals. The company...
Oncology translational model: tumor organoid dependency biobank
Researchers built a publicly available tumor organoid biobank covering 256 clinically annotated models across colorectal, oesophageal, ovarian, pancreatic, and gastric cancers. The dataset links...