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Regulatory—rare blood disorder therapy
Takeda and Protagonist Therapeutics’ rusfertide, to be branded as Mimrylo, received FDA approval for polycythemia vera, a rare myeloproliferative blood disorder. The regulatory nod makes the first...
FDA approvals—autoimmune inflammation drug
Roivant’s Priovant gained FDA clearance for Lisraya (brepocitinib), an oral JAK1/TYK2 inhibitor, to treat dermatomyositis. The approval marks a major regulatory milestone for the hub-and-spoke...
FDA fast-track—ADC for metastatic colorectal cancer
CytomX Therapeutics’ EpCAM-directed masked ADC varsetatug masetecan (Varseta-M; CX-2051) received FDA fast track designation for relapsed/refractory metastatic colorectal cancer. The designation...
Phase 3 readout—immune disease expansion path for tezepelumab
AstraZeneca and Amgen reported positive phase 3 results for tezepelumab (Tezspire) in eosinophilic esophagitis (EoE), with coprimary endpoints and key secondary endpoints met in the Crossing...
Deal—Roche bets on next-gen ADC payload platform
Genentech agreed to a collaboration and license deal with Shanghai-based DualityBio built around the company’s DUPAC payload platform for antibody-drug conjugates. Roche will pay $45 million...
Anticipated biotech money—large financing and market activity
Biopharma fundraising and dealmaking momentum stayed strong into late August, with Modernas latest capital raise and continuing high-value transaction flow underscoring risk-on activity. The...
M&A—healthcare services deal for oncology commercialization and trial ops
McKesson will acquire Precision Medicine Group in a deal valued at about $2.25 billion, positioning the distributor and services company deeper into clinical research and biopharma...
Patent litigation—single-cell multi-epitope IP dispute
A U.S. jury found that Parse Biosciences, a Qiagen subsidiary, willfully infringed three patents held by Scale Biosciences—assets acquired by 10x Genomics in 2025—relating to methods for...
Clinical innovation failure—BioNTech scraps personalized mRNA cancer vaccine phase 2
BioNTech and Genentech terminated a phase 2 trial of their personalized mRNA cancer vaccine, according to reporting that followed Merck and Moderna’s phase 3 success in a different personalized...
Regulatory approvals – metabolic and cardiovascular benefit
Eli Lilly’s Mounjaro (tirzepatide) cleared an FDA approval aimed at reducing major cardiovascular events in adults with type 2 diabetes at high risk, building on cardiovascular outcomes data from...
Regulatory approvals – rare autoimmune inflammatory disease
Priovant Therapeutics, a Roivant unit, won FDA approval for Lisraya (brepocitinib) to treat dermatomyositis, marking a first regulatory nod for a once-daily, oral approach designed to block JAK1...
Cardiovascular – ATTR-CM “silencers” hit headwinds after phase 3 failure debate
A Phase 3 setback for AstraZeneca and Ionis’ eplontersen (Wainua) is taking center stage as investors and cardiology stakeholders parse why the trial missed its primary objective—against the...
Oncology – ADC pipeline advances with fast-track interest and novel payload strategy
CytomX Therapeutics won FDA fast track designation for varsetatug masetecan (CX-2051), an EpCAM-directed masked antibody-drug conjugate for relapsed/refractory metastatic colorectal cancer. The...
Oncology – major partnership for next-generation ADC payloads
Genentech entered a multi-stage deal with DualityBio to advance antibody-drug conjugates designed for resistance to topoisomerase inhibitor payloads. Under the agreement, DualityBio receives $45...
Rare disease – FDA approval for protein engineering in polycythemia vera
Takeda and Protagonist Therapeutics won FDA approval for rusfertide, a new therapy for polycythemia vera branded as Mimrylo. The decision creates a new treatment option for a rare blood disorder...
Regulatory and reimbursement – companion diagnostics expand access to targeted oncology
Agilent Technologies reported FDA approvals for additional PD-L1 companion diagnostic assays and raised fiscal guidance after a strong third-quarter performance. Among the regulatory items, the...
Clinical development – Aprea expands Phase 1 WEE1 inhibitor program after early activity signals
Aprea Therapeutics moved to accelerate enrollment and broaden cohorts in its Phase 1 program for APR-1051, an oral WEE1 kinase inhibitor, after early clinical activity signals. The company plans...
Cell therapy – CAR-T meets manufacturing disruption as BMS ends CDMO collaboration
Bristol Myers Squibb ended its partnership with Cellares, a chimeric antigen receptor T-cell manufacturing and workflow partner. Cellares said a “large pharmaceutical customer” decided to...
Diagnostics reimbursement and platform expansion – MRD testing gains CMS coverage for immunotherapy monitoring
NeoGenomics announced expanded Centers for Medicare and Medicaid Services (CMS) Molecular Diagnostic Services Program (MolDX) coverage for its tumor-informed MRD assay RaDar ST, adding...
Regulatory approvals - GLP-1/GIP cardiovascular outcomes
FDA approved Eli Lilly’s Mounjaro (tirzepatide) to reduce cardiovascular risk in adults with type 2 diabetes, extending the drug’s label beyond glucose lowering, weight loss, and glycemic control....