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ArkBio’s completion of Phase I dosing for AK0406 moves the investigational long-acting influenza prophylaxis candidate into extended safety, pharmacokinetic and immunogenicity follow-up. Representative image.
Pharma & Biotech

What does ArkBio’s AK0406 dosing milestone mean for long-acting influenza prevention?

ArkBio has dosed all Phase I cohorts of AK0406, moving the long-acting influenza prophylaxis candidate into six-month safety follow-up.

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JCR Pharmaceuticals’ IZCARGO UAE marketing authorization expands access to a blood-brain barrier-penetrating enzyme replacement therapy for Hunter syndrome. Representative image.
Pharma & Biotech

IZCARGO has moved beyond Japan, but JCR Pharmaceuticals’ real test begins after the UAE authorization

JCR Pharmaceuticals’ UAE authorization for IZCARGO opens a new market, but reimbursement, supply and Phase III evidence will shape its impact.

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European Commission approval of Kyowa Kirin’s Crysvita expands X-linked hypophosphataemia treatment to infants from one month of age across the European Union. Representative image.
Pharma & Biotech

Kyowa Kirin wins European Crysvita approval for infants from one month of age

Crysvita wins European Union approval for infants from one month, widening early XLH treatment and strengthening Kyowa Kirin’s rare disease franchise.

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MultiDimension Technology’s TMR1370 ultra-low-power magnetic switch targets longer battery standby and greater design flexibility in continuous glucose monitoring devices. Representative image.
Medical Devices & Diagnostics

Why MultiDimension Technology’s tiny 50 nA chip could matter before a CGM is ever worn

MultiDimension Technology’s TMR1370 targets two-year CGM standby with 50 nA current, but device-level validation will decide its impact.

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GemPharmatech and Humlab Global are expanding global access to humanized mouse models for liver disease, oncology and preclinical drug research. Representative image.
Pharma & Biotech

GemPharmatech just added a humanized liver model, but can it close the clinical translation gap?

GemPharmatech and Humlab Global expand access to humanized mouse models, but validation and adoption will determine their clinical value.

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Kelun-Biotech’s sacituzumab tirumotecan plus pembrolizumab met the Phase III PFS endpoint in first-line PD-L1-negative non-squamous NSCLC. Representative image.
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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Representative image of radiopharmaceutical preparation and PET imaging, illustrating how the Sanyou Bio and Baiyunshan Xihe collaboration aims to combine AI-led antibody discovery with nuclear medicine development for precision oncology.
Medical Devices & Diagnostics

AI meets nuclear medicine as Sanyou Bio and Baiyunshan Xihe pursue cancer diagnostics

Explore how Sanyou Bio and Baiyunshan Xihe are combining AI discovery and nuclear medicine to advance precision oncology theranostics.

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Otsuka’s VOYXACT Phase 3 VISIONARY results showed sustained kidney function benefits in adults with IgA nephropathy, strengthening the case for long-term disease modification and full regulatory approval. Representative image.
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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Representative image: Laboratory research into EXG-7001 highlights Nippon Shinyaku and Elixirgen Therapeutics’ effort to develop a full-length dystrophin mRNA therapy for Duchenne muscular dystrophy.
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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Representative image: Otsuka’s centanafadine Phase 3b results highlight the investigational ADHD treatment’s potential in adults with comorbid anxiety ahead of the FDA decision.
Pharma & Biotech

Could centanafadine reshape nonstimulant ADHD treatment after Otsuka’s Phase 3b success?

Discover how Otsuka’s centanafadine Phase 3b ADHD data could shape FDA review and the nonstimulant treatment market. Read more.

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