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FDA clears first neurostimulation device for PTSD veterans via VA
Neurovalens won FDA de novo clearance for its Modius Spero wearable neuromodulation device for PTSD symptoms, giving U.S. veterans access through the Department of Veterans Affairs this summer....
Vertex expands pediatric access for sickle cell gene therapy; United Therapeutics buys thymus cell startup
Vertex’s Casgevy received authorization for children, enabling use for sickle cell disease with recurrent vaso-occlusive crises and transfusion-dependent β-thalassemia in younger patients. The...
Genentech claims head-to-head Phase 3 edge for KRAS G12C inhibitor divarasib in NSCLC
Roche’s Genentech reported superior Phase 3 results for divarasib (KRAS G12C inhibitor) in previously treated non-small-cell lung cancer, with the Phase 3 Krascendo-1 trial showing clinically...
Regenerative medicine deal: Ipsen acquires Memo Therapeutics for BK polyomavirus kidney transplant nephropathy antibody
Ipsen agreed to acquire Memo Therapeutics for up to €700 million, adding potravitug, Memo’s Phase II monoclonal antibody targeting the BK virus VP1 capsid protein. The asset is aimed at BK...
AstraZeneca and CSPC return for another kidney drug discovery pact worth up to $1.7B
AstraZeneca expanded its China collaboration with CSPC Pharmaceutical through a kidney-focused drug discovery pact. AstraZeneca will pay CSPC $30 million upfront to jointly discover and develop...
Brightpath files IND in the U.S. for multiple myeloma candidate BP-2202
Brightpath Biotherapeutics submitted an IND application to the FDA to start a Phase I trial of BP-2202 in the U.S. The trial is registered as NCT07667868, marking the program’s regulatory step...
Celea raises $180M to push deupirfenidone into late-stage idiopathic pulmonary fibrosis testing
Celea Therapeutics, backed by PureTech, raised $180 million to advance deupirfenidone, its retooled pirfenidone-derived candidate for idiopathic pulmonary fibrosis (IPF). The company plans to...
Orca Bio gets landmark FDA approval for Treg-based cell therapy Tregzi
Orca Bio received a landmark FDA nod for Tregzi, becoming the first FDA-approved cell therapy built on regulatory T cells (Tregs). Clinical trial results showed a reduced risk of graft-versus-host...
One Biosciences moves its single-cell profiling platform into clinical trials with Adcytherix ADCX-020
One Biosciences is bringing its OneMap single-cell molecular profiling platform into clinical studies for the first time, partnering with French company Adcytherix to advance its lead ADC...
Sandoz launches direct-to-consumer platform for growth disorder therapy as generic maker expands access model
Sandoz unveiled a direct-to-consumer platform starting with a single growth disorder medication, signaling the generic business’s push to reduce out-of-pocket costs for some patients. The...
FDA approvals and regulatory milestones for next-generation cell therapies
Orca Bio won FDA approval for Tregzi, a precision-engineered regulatory T-cell therapy designed to improve outcomes in matched-donor allogeneic HSCT for adults with hematologic malignancies. The...
Oncology clinical data: head-to-head Phase 3 win in KRAS G12C NSCLC
Roche’s Genentech unit reported new head-to-head Phase 3 data showing its KRAS G12C inhibitor divarasib outperformed approved therapies in previously treated non-small-cell lung cancer. In the...
Big pharma dealmaking in China: AstraZeneca expands kidney R&D pact with CSPC
AstraZeneca extended its China collaboration with CSPC Pharmaceutical through a new kidney disease drug discovery and development pact worth up to $1.7 billion. AstraZeneca will pay CSPC $30...
Rare-disease cellular and regenerative pipeline: United Therapeutics buys Thymmune for thymic cell therapy
United Therapeutics agreed to acquire Thymmune Therapeutics for $140 million upfront, with up to $160 million more tied to milestones, to expand its regenerative cell-therapy pipeline focused on...
IPOs and capital formation in early-stage biotech
Scribe Therapeutics filed for a Nasdaq IPO, setting up a liquidity event for the clinical-stage CRISPR enzyme developer as investors assess demand for early gene-editing exposure. The filing marks...
Biotech financing: PureTech-backed Celea launches $180M push into late-stage IPF
Celea Therapeutics, backed by PureTech, raised $180 million to advance deupirfenidone, a next-generation idiopathic pulmonary fibrosis therapy positioned as a retooled version of pirfenidone. The...
Clinical trial enabling tech: single-cell profiling platform moves into ADC patient selection studies
One Biosciences expanded its single-cell profiling platform into clinical trials for the first time by supporting Adcytherix’s ADC program. Under the collaboration, One Biosciences will help...
Genomics infrastructure: automated genomic reanalysis tool Talos scales rare-disease diagnosis
An open-source automated genomic reanalysis tool called Talos showed strong rare-disease diagnostic yield in a study published in Nature Medicine. Researchers tested Talos on the genomes of 4,735...
Regenerative medicine engineering: reproducible kidney organoids via synthetic Wnt organizers
USC researchers combined spatial mapping of kidney development with synthetic cell engineering to produce more reproducible kidney organoids from human pluripotent stem cells. In a Science report,...
Organs-on-a-chip and cell-counting innovation: single-molecule precision PCR spotlight
Countable Labs presented a PCR platform aimed at single-molecule quantification, targeting two persistent challenges in molecular measurement: rare-event sensitivity and run-to-run...