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EU approvals after FDA setback
Europe’s regulators moved forward on Sanofi’s multiple sclerosis program after the U.S. FDA rejected the company’s BTK inhibitor strategy. The EMA’s CHMP recommended approval for Cenrifki...
Phase III readout countdown and leadership refresh
Inventiva accelerated boardroom change and signaled continuity as it targets a Phase III readout for lanifibranor in MASH. The French biotech named new executives across finance, legal, and people...
FDA approval via national priority vouchers
Regeneron won the first FDA approval under the agency’s national priority voucher framework with Otarmeni, an AAV-mediated gene therapy for a rare inherited hearing loss. The therapy is cleared...
Revenue and label momentum for multiple sclerosis economics
Sanofi’s Dupixent partner Regeneron secured U.S. clearance for a pediatric chronic spontaneous urticaria label expansion, while Sanofi’s broader financial picture remained supported by earnings...
Cancer cell therapy M&A escalates in 2026
UCB moved quickly into epilepsy-focused cell therapy dealmaking by acquiring Neurona Therapeutics for up to $1.15 billion. The Belgian pharma’s purchase adds Neurona’s NRTX-1001, an epilepsy lead...
CAR-T and next-gen cell therapy enters wider solid tumor targeting
A new CAR-T design aimed at avoiding continuous activation showed early signals against multiple solid tumor types. Researchers at the University of Pennsylvania presented first-in-human Phase I...
C-suite, corporate actions, and product pipeline risk: CRL hits GTx-104
Grace Therapeutics faced a regulatory setback for its aneurysmal subarachnoid hemorrhage program despite earlier positive trial results. The FDA issued a complete response letter (CRL) for the...
Capital markets: Inventors and startups pursue new funding routes
Ray Therapeutics raised new growth capital to push a retinal gene therapy into later-stage clinical development. The company closed a $125 million Series B financing to support late-stage trials...
Foundational imaging and AI tooling for diagnosis
Researchers at City of Hope and UC Berkeley reported a microfluidic AI platform that ties mechanical properties of single breast epithelial cells to cancer susceptibility. The mechano-node-pore...
Biopharma policy and regulatory disclosure pressure
An unnamed pharma company asked regulators to change how the FDA publicly discloses complete response letters. The citizen petition targets the FDA’s July 2025 policy to release CRLs, arguing the...
FDA gene therapy approval (hearing loss) under National Priority Voucher program
The FDA approved Regeneron’s Otarmeni (lunsotogene parvec), the first gene therapy cleared under the agency’s National Priority Voucher program. The treatment is authorized for hearing loss due to...
EU regulatory greenlight after U.S. FDA rejection: Sanofi’s tolebrutinib (nrSPMS)
Sanofi’s tolebrutinib (branded Cenrifki) cleared another step for multiple sclerosis in Europe after the FDA had issued a complete response letter in the U.S. for treatment of non-relapsing...
FDA CRL setback: Grace Therapeutics’ GTx-104 for aneurysmal subarachnoid hemorrhage
Grace Therapeutics said the FDA issued a complete response letter for its GTx-104 NDA, delaying the company’s attempt to update the standard of care for aneurysmal subarachnoid hemorrhage. Grace...
Biopharma dealmaking: UCB’s up-to-$1.15B acquisition of Neurona Therapeutics
UCB announced an agreement to buy Neurona Therapeutics in a deal valued at up to $1.15 billion, including $650 million upfront and milestone payments. Neurona’s lead asset, NRTX-1001, is focused...
New European imaging and analytics tools (product launches) for oncology and translational research
New diagnostics and spatial analytics launches rolled out for research and translational programs. Qlucore introduced Qlucore Insights for bladder cancer, a research-use-only...
Venture capital: Kurma Partners closes €215M fund
Kurma Partners closed its fourth and largest venture fund, raising €215 million, targeting investments in disruptive therapeutic companies. Kurma said previous exits included Corlieve...
U.S. corporate expansion for single-cell tumor ecosystem profiling: One Biosciences picks Albany
One Biosciences will establish its first U.S. location in Albany, New York, building and staffing a high-complexity lab and computational analytics operation. Institut Curie-backed, the company...
FDA-CMS coverage alignment for breakthrough medical devices (RAPID pathway)
The FDA and CMS announced a new regulatory pathway—Regulatory Alignment for Predictable and Immediate Device, or RAPID—to speed Medicare national coverage decisions for breakthrough medical...
Cell therapy platform scaling: bioreactor method for weekly macrophage production
Researchers at Hannover Medical School (MHH) published a method to produce human immune cells in medium-sized bioreactors, converting induced pluripotent stem cells into immune-cell factories. The...
Drug development pipeline: ATR inhibition strategy advances with alnodesertib
Artios is advancing alnodesertib, an oral ATR inhibitor with an N-linked sulfoximine intended to improve selectivity within the PIKK family. Early combination results with irinotecan reported...