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M&A reshapes the CNS market
Supernus Pharmaceuticals and Indivior Pharmaceuticals agreed to a tax-free, all-stock merger that combines complementary neuroscience portfolios, with leadership consolidated under Supernus and...
Radiopharma consolidation and theranostics scale-up
Curium struck a definitive agreement to acquire Lantheus in a deal valued up to roughly $8 billion, aiming to combine Curium’s theranostics manufacturing network with Lantheus’ U.S....
FDA moves Pluvicto earlier in prostate cancer
The FDA expanded Novartis’ Pluvicto label, clearing the radioligand therapy for use alongside hormone therapy in an earlier setting of metastatic prostate cancer. The update nearly doubles the...
Regulatory approval for subcutaneous head and neck cancer regimen
The FDA granted Priority Review to a supplemental biologics license application for Johnson & Johnson’s RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) in recurrent or metastatic head and...
Strategic genomics expansion through acquisition
Hinge Health agreed to buy digestive health startup Cylinder Health in a $105 million cash deal, extending the virtual physical therapy platform into chronic digestive care. The acquisition...
Tempus moves to acquire Personalis after strong quarter
Personalis reported a 30% year-over-year revenue rise in Q2, driven by growth in pharma testing services and an increase in covered clinical lung cancer and immune-oncology monitoring. The company...
Device regulation: CE mark for aneurysm embolization system
Galaxy Therapeutics received CE mark approval under the European Medical Device Regulation for its SEAL embolization system, designed for treatment of ruptured and unruptured wide-neck...
AI-enabled platform partnerships in oncology ADCs
Pathos AI expanded its oncology licensing and collaboration portfolio by signing multiple deals tied to bispecific ADC and degrader programs. The company acquired rights to a bispecific...
Gene-editing safety and oversight under scrutiny after death
A 6-year-old girl died after receiving an experimental brain-directed gene-editing therapy at Xinhua Hospital in Shanghai, prompting renewed scrutiny of how regulators oversee first-in-human...
Venture-backed CRISPR startup halts lead program
STAT+ reported that Aurora Therapeutics, a startup building personalized gene-editing therapies, scrapped its lead program and cut staff just seven months after launching. The move follows...
Regulatory shift on gray-market peptides and compounding access
An FDA advisory committee approved moving six of seven “gray market” peptide compounds off the FDA’s CAT2 designation and onto the 503A bulk substance list, according to the committee’s vote and...
R&D measurement and outcome assessment gaps driving neurologic trial failures
A new study argues that many neurologic and psychiatric clinical trial failures stem less from biology and more from measurement tools that cannot detect meaningful treatment effects. The authors...
Precision oncology enters earlier prostate-cancer setting with Pluvicto label expansion
The FDA expanded Novartis’ radioligand therapy Pluvicto into an earlier stage of PSMA-positive prostate cancer by granting supplemental approval for patients with metastatic hormone-sensitive...
Radiopharma consolidation: Curium to acquire Lantheus in up-to-$8B deal
Curium and Lantheus announced a definitive agreement under which Curium will buy all outstanding Lantheus shares for $102.50 each in cash at closing, with potential contingent value rights that...
CNS portfolio merger: Supernus to combine with Indivior in all-stock deal
Supernus Pharmaceuticals and Indivior agreed to a “merger of equals” to create a CNS-focused company under the Supernus name. The transaction is structured as an all-stock deal with an expected...
Diagnostics: Sophia Genetics lands CDx collaboration with AstraZeneca as revenue rises
Sophia Genetics reported Q2 revenue grew 27% year over year, driven by U.S. customer expansion and liquid biopsy sales, and announced a companion diagnostics collaboration with AstraZeneca. The...
Molecule and platform pipeline: Satellite Biosciences gets IND clearance for SB-101 in urea cycle disorders
Satellite Biosciences received FDA IND clearance for SB-101, an investigational therapy for urea cycle disorders, with a Phase I/II trial planned in infants with severe, early-onset urea cycle...
Biotech funding: Inocras closes additional $31M Series B-3 for whole-genome sequencing expansion
Inocras closed a $31 million Series B-3 round for its clinical genome sequencing platform, according to the company. Existing investors DSC Investment, Dunamu and Partners, and InterVest...
Manufacturing and instrumentation: GE Healthcare and DNA Script receive up to $26M ARPA-H funding for FLASH enzymatic DNA synthesis
GE Healthcare and DNA Script were awarded up to $26 million from HHS’ Advanced Research Projects Agency for Health (ARPA-H) under the Advanced Manufacturing Incubator for DNA program. The...
AI in drug discovery meets capital markets: Twist reports growth and points to AI-driven therapeutics orders
Twist Bioscience reported fiscal Q3 2026 revenue of $118.4 million, up 23% year over year, and said the company is forecasting major growth driven by customer interest in using AI as a first...