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ASCO oncology trial updates: pancreatic and melanoma approvals seek momentum
Revolution Medicines began shipping daraxonrasib to physicians and patients under an FDA-authorized early access program for pancreatic cancer. The company said patients have been seeking access...
Late-stage hematology gains: multiple myeloma CELMoD and PARP–ARPI strategy readouts
Bristol Myers Squibb presented Phase 3 SUCCESSOR-2 data showing mezigdomide improved progression-free outcomes in relapsed/refractory multiple myeloma when added to carfilzomib and dexamethasone....
ASCO diagnostic evidence standards: MCED Galleri not recommended
ASCO said it will not recommend Grail’s Galleri multi-cancer early detection test for screening guidelines after reviewing new trial data. The coverage highlighted that the NHS-Galleri randomized...
New imaging and diagnostic tools: Tempus liquid biopsy and point-of-care molecular testing
Tempus AI received FDA approval for a tumor-only indication for its xT CDx next-generation sequencing assay. The update allows the assay to run without a matched normal specimen (blood or saliva)...
Oncology drug precision and delivery innovation
Researchers described a peptide-directed, hypoxia-sensitive AAV system designed to enhance tumor-specific delivery in non-small cell lung cancer. The platform uses capsid retargeting plus...
Cell therapy and corporate leadership change
Allogene Therapeutics announced management turnover, with CMO Zachary Roberts set to succeed David Chang as president and CEO on June 1. Chang, an Allogene co-founder, will stay on the board after...
Pipeline and approval pathway for hepatitis B functional cure
A Phase 3 program of bepirovirsen in chronic hepatitis B reported a functional cure signal after fixed-duration therapy. In two replicate randomized trials (B-Well 1 and B-Well 2), the proportion...
AI-first operations in patient access and diagnostics platforms
CareTria acquired CaryHealth, aiming to build an AI-enabled direct-to-patient pharmacy platform that connects therapy initiation and adherence workflows. The integrated system combines automated...
Hepatitis B “functional cure” heads into clinical-discontinuation readouts
GSK reported Phase 3 bepirovirsen results for chronic hepatitis B that show a functional cure rate after stopping background nucleoside/nucleotide therapy. In two replicate trials (B-Well 1 and...
FDA actions and regulatory pathways reshape oncology approvals and re-submissions
FDA clearance reached AbbVie’s CD123-targeting antibody-drug conjugate Decnupaz (pivekimab sunirine) for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN), marking a regulatory win...
Big Pharma doubles down on China-based ADC and multispecific discovery pipelines
Pfizer and Innovent Biologics announced a broad multi-drug R&D collaboration for antibody-drug conjugates and multispecific antibodies across 12 oncology programs, with Innovent receiving $650...
Multiple myeloma: CELMoD-based regimen doubles PFS in Phase 3 SUCCESSOR-2
Bristol Myers Squibb disclosed Phase 3 SUCCESSOR-2 results for mezigdomide (MeziKd) in relapsed or refractory multiple myeloma, reporting a 52% reduction in risk of disease progression or death...
Multiple myeloma pipeline: successor program mezigdomide extends into a published PFS headline
Bristol Myers Squibb’s mezigdomide continues to build toward regulatory and label strategy after it reported SUCCESSOR-2 success, reinforcing the company’s push for next-generation multiple...
Oncology trials at ASCO: ovarian cancer AD C and bladder cancer competition builds
Gilead updated clinical data at ASCO on TUB-040, its antibody-drug conjugate tied to the Tubulis buyout, with the latest readout presented as supportive of the program’s continued development in...
Diagnostic shift: Tempus wins FDA approval for tumor-only sequencing for xT CDx
Tempus AI secured FDA approval for a tumor-only indication for its xT CDx next-generation sequencing assay, expanding how the 648-gene platform can be used for molecular profiling of solid tumors....
Regenerative and community clinical integration: CDL-Cleveland launches direct hospital innovation hub
Creative Destruction Lab launched CDL-Cleveland with University Hospitals and Case Western Reserve University, creating a direct clinical integration platform aimed at moving biomedical startups...
Cell therapy leadership change: Allogene CEO David Chang steps down
Allogene Therapeutics said Zachary Roberts will succeed David Chang as president and CEO after Chang’s eight-year tenure at the off-the-shelf CAR-T company. The move is set to take effect July 1...
CAR-T platform development: Allogene swap in CMO role after CEO transition
Following the announcement of David Chang’s exit, Allogene’s executive changes are continuing with the company repositioning leadership around its CMO and R&D functions. The update places Zachary...
Mega-deal: Pfizer and Innovent expand into ADCs and multispecifics
Pfizer struck a broad oncology collaboration with Innovent Biologics to develop 12 antibody-drug conjugates and multispecific antibody programs, anchored by early-stage discovery from Innovent and...
FDA resubmission attempt: Replimune eyes RP-1 melanoma after biotech leadership churn
Replimune said it reached alignment with the U.S. FDA to resubmit its melanoma biologic RP-1 (vusolimogene oderparepvec) after two prior rejections. The company plans to file the biologics license...