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FDA approvals in cardiometabolic and regulatory momentum
The FDA approved AstraZeneca’s baxdrostat (Baxfendy), a first-in-class aldosterone synthase inhibitor, for hypertension in combination with other antihypertensive medications for patients whose...
Late-stage rare disease failure reshapes approvals outlook
BioMarin’s Phase 3 program for its ENPP1 deficiency therapy landed below regulatory expectations, missing a key goal in a rare inherited enzyme deficiency study. The results add uncertainty around...
Epigenomics and platform partnerships for drug discovery
EpiCypher expanded its commercialization partnership with New England Biolabs to broaden epigenomics tool development and distribution. The companies are extending their workflow collaboration...
AI automation in experimental biology
Nature published new work on Robin, a multi-agent system designed to automate the scientific discovery loop for experimental biology. The system integrates literature-search agents with...
Diagnostic and screening expansion using liquid biopsy
Delfi Diagnostics presented interim clinical utility data for its cfDNA-based FirstLook Lung blood test in a cluster-randomized FIRSTLUNG study. The company reported that access to the assay...
Cell and gene therapy financing for in vivo CAR platforms
Create Medicines closed a $122 million Series B financing to support its pipeline of in vivo CAR therapies delivered by liquid nanoparticles. The company said the funding runway is expected to...
Regulatory and market access for clinical trial infrastructure
The European Medicines Agency proposed a centralized approach to help harmonize and speed clinical trial contracts across Europe. In its clinical trial highlights newsletter, EMA said stakeholders...
Monoclonal and platform expansion in hepatocellular carcinoma diagnostics
Helio Genomics expanded commercialization for its HelioLiver blood-based liver cancer screening test by partnering with Syneos Health. The companies said the deal is intended to broaden adoption...
Regulatory and policy
The European Medicines Agency (EMA) proposed a centralized support platform to standardize clinical trial contracting across the EU, aiming to reduce delays that sponsors face when negotiating...
FDA approvals and clearance
The FDA cleared Diasorin’s customizable syndromic GI multiplex PCR panel, expanding the LIAISON Plex Gastrointestinal Flex Assay menu. The test detects 24 pathogens—bacteria, viruses, and...
Biotech funding and capital formation
AI biotech startup Blank Bio raised a $7.2 million seed round to develop and commercialize RNA foundation models aimed at precision medicine, with an initial focus on oncology. Investors included...
Clinical trials and efficacy readouts
Relay Therapeutics reported Phase 2 efficacy for zovegalisib (RLY-2608) in patients with PIK3CA-driven vascular anomalies, posting a 60% volumetric response. The signal exceeded expectations and...
Phase 3 in obesity and regulatory submissions
Vincentage Pharma said its once-daily oral small-molecule GLP-1 receptor agonist, VCT-220, met primary endpoints in a pivotal Phase 3 trial in overweight or obese patients in China. The company...
Drug deals and rights acquisitions
Fosun Pharmaceutical secured an option to obtain exclusive rights to Aribio’s oral Phase 3 Alzheimer’s disease therapy, AR-1001, in a deal valued at up to $4.7 billion. Fosun will pay $60 million...
Oncology drug development and trial strategy
Cyclana Bio received UK NHS approval to start its Predicting Endometriosis Mechanisms and Populations (PEMP) observational study aimed at identifying endometriosis biomarkers and druggable...
Company launches, expansions, and tech platforms
EpiCypher and New England Biolabs (NEB) expanded their epigenomics partnership, extending commercialization of CUT&RUN and CUT&Tag workflows. The expanded collaboration now includes CUTANA...
AI in drug discovery and healthcare
DeepMind and Edison Scientific said they are building an “AI scientist,” expanding the push toward autonomous systems that connect hypothesis generation, experimental design, and data...
Diagnostics and translational evidence
Delfi Diagnostics said a cluster-randomized trial found its cfDNA-based FirstLook Lung blood test increased lung cancer screening uptake about threefold versus usual care among patients behind on...
Regulatory approval: first-in-class hypertension therapy
AstraZeneca won a key US regulatory milestone as the FDA approved Baxfendy (baxdrostat), an aldosterone synthase inhibitor, for patients with hypertension that remains inadequately controlled on...
Alzheimer’s licensing deal: Fosun secures AR-1001 option
Shanghai Fosun Pharmaceutical acquired an option to secure exclusive rights to Aribio’s oral phase III-stage Alzheimer’s disease therapy AR-1001 in a deal that can scale to $4.7 billion. Fosun...