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Regulatory affairs – FDA user fees and review operations
The White House is reviewing the next FDA user-fee agreement covering 2028 through 2032, according to sources. The prospective deal would determine how much the biopharma industry pays the agency...
Oncology – Combination trial wins expand multiple myeloma options
Bristol Myers Squibb reported Phase 3 results showing its CELMoD mezigdomide, added to carfilzomib plus dexamethasone, cut the risk of progression or death by 52% in relapsed or refractory...
Oncology – Early-access authorization for investigational pancreatic cancer therapy
Revolution Medicines began shipping its investigational pancreatic cancer drug daraxonrasib under an FDA-authorized early access program, CEO Mark Goldsmith said. The therapy is not yet approved,...
Oncology – Mega-deal expands China-built antibody-drug conjugates and multispecifics
Pfizer struck a broad multi-drug R&D collaboration with Innovent Biologics covering up to 12 oncology programs, including antibody-drug conjugates and multispecific antibodies. Pfizer will take...
Immuno-oncology – ASCO weighs evidence for multi-cancer early detection testing
ASCO will not recommend Grail’s Galleri multi-cancer early detection test for inclusion in cancer screening guidelines after reviewing data from a large, prospective randomized trial. The...
Gene therapy – Replimune pushes FDA resubmission for advanced melanoma
Replimune said it reached alignment with the U.S. FDA to resubmit its BLA for RP-1 (vusolimogene oderparepvec) in advanced melanoma after two prior rejections. The company characterized FDA...
Diagnostics – FDA clears tumor-only indication for Tempus xT CDx sequencing
Tempus AI received FDA approval for a tumor-only indication for its xT CDx next-generation sequencing platform, expanding how clinicians can use the 648-gene tissue assay. Previously, the test...
Biomanufacturing and platforms – Portable, freeze-dried reagents expand access to biomanufacturing tools
Researchers from the University of Toronto’s Leslie Dan Faculty of Pharmacy demonstrated freeze-dried reagent and hand-powered hardware workflows designed to bring biomanufacturing and diagnostics...
Virology and maternal-fetal medicine – Dual host-targeting therapy blocks pregnancy complications
Researchers described a host-directed dual therapy intended to prevent virus-induced pregnancy complications by targeting cyclophilin A and suppressing the pathogenic interferon response. The...
Protein intelligence and discovery – ESM Atlas expands predicted protein structures beyond AlphaFold scales
The Chan Zuckerberg Initiative’s Biohub released the ESM Atlas, an open (or openly available) resource comprising more than one billion predicted protein structures and billions of sequences...
FDA regulatory framework shift and user-fee negotiations
A new report says the White House is reviewing the next FDA prescription drug user fee deal covering 2028–2032, setting up a key policy lever for how much authority the agency and industry will...
Big pharma–China partnerships in oncology
Pfizer struck a broad oncology collaboration with Innovent Biologics, committing $650 million upfront and up to $9.85 billion in milestones to co-develop a portfolio spanning 12 early-stage and de...
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...