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Gene therapy safety—FDA pauses Regenxbio Hunter syndrome program
FDA again paused trials for Regenxbio’s Hunter syndrome gene therapy after safety findings tied to spine MRI abnormalities in five treated patients, according to the company’s disclosure and STAT+...
Obesity deals—Roche locks in Hanmi muscle-sparing asset
Roche secured rights to Hanmi Pharmaceutical’s obesity drug candidate designed to increase muscle mass while reducing fat, the company disclosed via a deal reported in industry coverage. Roche...
Alzheimer’s diagnostics—FDA clears Roche/Lilly blood-based biomarker test
Roche and Eli Lilly received U.S. FDA clearance for Elecsys Phospho-Tau (217P) Plasma, a blood test intended to identify amyloid pathology associated with Alzheimer’s disease. The assay targets...
Device approval—FDA grants humanitarian approval to Oncosil brachytherapy
The U.S. FDA awarded a humanitarian device exemption (HDE) approval to Oncosil Medical’s Oncosil brachytherapy device for distal cholangiocarcinoma, according to the company’s disclosure. Oncosil...
Cell therapy regulatory clock—FDA extends review for Capricor deramiocel
The FDA extended its review of Capricor Therapeutics’ deramiocel, pushing the PDUFA decision timeline as the agency seeks additional information for a refined indication. Capricor said the...
Gene sequencing IP—TwinStrand victory forces payouts from Guardant
A U.S. District Court ordered Guardant Health to pay TwinStrand Biosciences and the University of Washington more than $245 million over patent infringement tied to duplex sequencing methods. The...
Diagnostic QA & access—WHO prequalification opens for TB IGRA and targeted NGS tests
WHO opened a prequalification pathway for interferon gamma release assays (IGRAs) and targeted next-generation sequencing (tNGS)-based tuberculosis in vitro diagnostics. The initiative is intended...
Corporate/clinical-stage expansion—Ambros merger with Werewolf advances CRPS asset
Werewolf Therapeutics and Ambros Therapeutics entered a definitive merger agreement that pairs the CRPS-1 drug neridronate with a public listing path, alongside an oversubscribed $150 million...
Biopharma pipeline ops—Rznomics joins Lilly Gateway Labs for RNA therapeutics buildout
Rznomics joined Lilly Gateway Labs in San Diego to accelerate discovery and development of RNA therapeutic candidates, the companies announced. The clinical-stage RNA platform company said it will...
GenAI regulation—FDA’s CDRH solicits input on regulating generative AI medical devices
The U.S. FDA’s Center for Devices and Radiological Health (CDRH) continued its GenAI regulatory discussion by inviting stakeholders to comment on a recently released discussion paper. The agency...
Regenxbio’s Hunter gene therapy faces renewed FDA action
FDA has placed Regenxbio’s Hunter syndrome gene therapy program under another clinical hold after MRI findings involving asymptomatic spine changes, derailing the company’s plan to refile for...
Capricor deramiocel reviews extended as agency requests more data
FDA has delayed its decision date for Capricor Therapeutics’ deramiocel, extending the agency’s review of the Duchenne muscular dystrophy program after the company submitted updated information...
Ambros completes Werewolf merger to fund pivotal CRPS-1 path
Werewolf Therapeutics and Ambros Therapeutics agreed to merge, with an oversubscribed $150 million private placement and a plan to advance neridronate toward a potential first FDA approval for...
WHO opens prequalification pathway for targeted NGS and TB IGRAs
WHO has officially opened its prequalification pathway for targeted next-generation sequencing (tNGS) and interferon gamma release assays (IGRAs) for tuberculosis in vitro diagnostics. The...
TwinStrand wins major duplex sequencing patent damages vs Guardant
A US District Court for the District of Delaware ordered Guardant Health to pay roughly $245 million in damages, royalties, and interest to TwinStrand Biosciences and the University of Washington...
Moderna and Merck’s intismeran autogene posts positive Phase III melanoma readout
Moderna and Merck announced positive topline Phase III results for their individualized neoantigen cancer vaccine, intismeran autogene, in combination with Merck’s Keytruda. In the INTerpath-001...
Roche expands obesity portfolio with Hanmi urocortin-2 analog deal
Roche agreed to pay $190 million upfront and up to $2.3 billion total for a clinical-stage obesity drug from Hanmi Pharm targeting the less-explored urocortin-2 pathway. The pact adds an...
Orum gets FDA clearance for IND on CD123-targeted GSPT1 degrader-antibody conjugate
FDA cleared Orum Therapeutics’ IND for ORM-1153, a CD123-targeting degrader-antibody conjugate designed to deliver a GSPT1 degrader payload to CD123-expressing cells. The program uses Orum’s...
Cell-free diagnostic pathway expands as WHO moves toward TB diagnostics prequalification
WHO’s prequalification rollout for targeted NGS and TB IGRAs is expected to widen access to next-generation tuberculosis diagnostics for global procurement. By defining policies and first-in-class...
Tech and automation investment signals momentum in sequencing and labs
BGI Genomics reported first-half 2026 revenue growth of 10% year over year, supported by precision medicine testing and multiomics services. The company said H1 revenue reached RMB 1.80 billion,...