Business, energy, technology, markets and global industry news from Business News Today

Inc.

Medical Devices & Diagnostics

FDA panel to review GRAIL Galleri cancer blood test after pivotal NHS trial misses primary endpoint

GRAIL, Inc. will face a potentially defining regulatory examination on September 23, 2026, when outside advisers to the United States Food and Drug Administration review the premarket approval application for its Galleri multi-cancer early detection blood test. The FDA’s Molecular and Clinical Genetics Panel is scheduled to discuss and vote on whether the available evidence

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Pharma & Biotech

argenx Forte Biosciences acquisition: What the $2.2bn FB102 deal means for immunology

argenx is buying Forte Biosciences for $2.2bn to secure FB102. See why early vitiligo and celiac data make Phase 2 execution decisive.

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Pharma & Biotech

Merck is licensing alimatravir before Phase 3 ends. Can a monthly HIV pill beat the access clock?

Merck’s alimatravir access plan covers 129 countries, but Phase 3 efficacy, pricing and regulatory execution will decide its HIV PrEP impact.

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Pharma & Biotech

Why Kelun-Biotech’s latest sac-TMT Phase III result could matter more than the headline suggests

Kelun-Biotech reports improved Phase III PFS with sac-TMT plus pembrolizumab, while survival and detailed safety data remain pending.

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Pharma & Biotech

Multikine is back in Phase 3, but can CEL-SCI turn a striking subgroup signal into approval?

CEL-SCI launches a 212-patient Multikine Phase 3 study, but subgroup validation, funding and regulatory execution remain decisive.

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Pharma & Biotech

Otsuka reports VOYXACT preserved kidney function for two years in Phase 3 trial

Otsuka’s two-year VOYXACT data could reshape IgA nephropathy care. See what the eGFR results mean for FDA approval and clinical adoption.

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Pharma & Biotech

Cogent advances third bezuclastinib FDA submission after APEX pivotal trial results

Cogent’s bezuclastinib NDA for advanced systemic mastocytosis is backed by APEX data showing 65% ORR and deep KIT-driven disease marker reductions.

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Pharma & Biotech

Can Merck’s IDVYNSO agreement widen HIV treatment access across state programmes?

See how Merck’s IDVYNSO ADAP agreement could widen HIV treatment access while pricing, formularies and clinical limits shape uptake.

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Pharma & Biotech

Nippon Shinyaku backs EXG-7001 as full-length dystrophin mRNA strategy enters Duchenne race

Discover how Nippon Shinyaku’s EXG-7001 option could advance full-length dystrophin mRNA therapy for Duchenne muscular dystrophy.

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Pharma & Biotech

Why HOPE Therapeutics’ first Zeta-guided TMS patients matter for psychiatry care

NRx’s HOPE Therapeutics begins Zeta-guided TMS treatments, bringing AI-powered image guidance into outpatient depression care workflows.

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