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Radiopharma deal reshapes US nuclear medicine footprint
Curium and Lantheus have agreed to merge in a deal valued at up to $8 billion, combining Curium’s theranostics manufacturing network with Lantheus’ U.S. radiodiagnostics franchise. Curium will buy...
FDA expands Pluvicto earlier in prostate cancer care
Novartis’ Pluvicto received an FDA label expansion to use alongside hormone therapy for patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC). The approval effectively...
Priority review for subcutaneous amivantamab in head and neck cancer
The FDA granted Priority Review to Johnson & Johnson’s supplemental biologics license application for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) in adults with recurrent or metastatic...
ARPA-H backs enzymatic DNA synthesis automation platform
GE Healthcare and DNA Script won up to $26 million from the U.S. Department of Health and Human Services’ ARPA-H under the Advanced Manufacturing Incubator for DNA program. The four-year...
FDA clearance pushes genomics into more routine transplant monitoring
Craig-Hallum upgraded CareDx to a Buy rating and raised its price target to $64 following a set of near-term and long-term growth drivers. The analyst cited expanded coverage and approved...
AI-focused startup expands across hospital networks for intake and diagnosis support
Akido is expanding its AI-assisted patient intake and diagnostic support across 100 clinics, pushing the startup’s “AI doctor” concept into broader clinical workflows. The deployment centers on...
IPO funds non-opioid Nav1.8 pipeline to challenge Journavx
Latigo Biotherapeutics filed for an IPO aiming to raise $247.2 million in net proceeds to develop a clinical-stage non-opioid pain portfolio built around Nav1.8 inhibition. The company plans to...
Biotech funds expansion for whole-genome diagnostics in US
Inocras raised $31 million in a Series B-3 round to expand its whole-genome sequencing platform and US commercial operations. Existing investors DSC Investment, Dunamu and Partners, and InterVest...
CNS consolidation: Supernus and Indivior merger closes with CNS portfolio build
Supernus and Indivior agreed to merge in a tax-free, all-stock “merger of equals,” forming a CNS-focused company expected to close in the fourth quarter of 2026. The combined firm will operate...
Regulatory: FDA adopts broader use for Pluvicto and amivantamab while grant policy tightens
In parallel regulatory moves, the FDA expanded Pluvicto’s use into earlier mHSPC and granted Priority Review to J&J’s subcutaneous amivantamab regimen for post-platinum head and neck cancer....
Oncology regulatory approvals and label expansion
The FDA expanded Novartis’ Pluvicto (lutetium Lu 177 vipivotide tetraxetan) into metastatic hormone-sensitive prostate cancer (mHSPC), approving the radioligand in combination with an androgen...
Radiopharmaceutical dealmaking to broaden theranostics footprint
Curium Pharma agreed to buy Lantheus in a deal valued up to about $8 billion, combining Curium’s theranostics manufacturing platform with Lantheus’ U.S. radiodiagnostics franchise. The transaction...
CNS-focused pharma consolidation
Supernus Pharmaceuticals and Indivior entered an all-stock “merger of equals” agreement to form a larger CNS-focused company, combining a portfolio of neuroscience and addiction medicines. The...
Drug safety and regulatory scrutiny around clinical effectiveness
Capricor’s resubmitted biologics license application for deramiocel (cardiosphere-derived cell therapy) faced a negative advisory outcome, with the FDA’s Cellular, Tissue, and Gene Therapies...
Biotech corporate M&A and deal rumors reshaping investor positioning
A rumored AstraZeneca–Bristol Myers Squibb mega-merger continued to shake investor sentiment, with reports indicating the companies held initial discussions. Media coverage tied the speculation to...
Biotech financing and market expansion signals
Inocras raised $31 million in a third Series B-3 round, expanding its whole-genome sequencing and bioinformatics platform. The company said it will use proceeds to expand whole-genome analysis...
Clinical translational science: blood-based biomarkers and precision decision support
Researchers at Johns Hopkins and the Bloomberg~Kimmel Institute reported that a single blood test using circulating tumor DNA (ctDNA) can indicate—within weeks—whether patients with advanced...
Immuno-oncology and resistance biology
Houston Methodist-led research identified a signaling pathway that may drive intrinsic resistance to trastuzumab deruxtecan in metastatic breast cancer. Published in Clinical Cancer Research, the...
Microbiome-linked therapeutics and infectious disease management
A first human case series combined phage therapy with fecal microbiota transplantation (FMT) to treat recurrent UTIs and reduce antibiotic use. Published in Nature Microbiology, the study...
Big pharma, payer policy, and federal program shifts impacting drug access
HHS is reviving a push for 340B rebate changes after an earlier pilot was blocked in court, according to a provider-focused report. Providers warned the shift would increase administrative and...