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United States Food and Drug Administration

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Laboratory research into next-generation obesity treatments highlights Ascletis Pharma Inc.’s preclinical ASC37 triple peptide agonist, which produced greater weight loss than tirzepatide in a diet-induced obese mouse study. Representative image.
Pharma & Biotech

Can Ascletis ASC37 become a once-monthly triple agonist for obesity?

Ascletis says ASC37 beat tirzepatide in obese mice, but human dosing, safety and durability remain untested ahead of a planned U.S. IND.

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Lundbeck’s investigational orexin 2 receptor agonist Lu AH69593 has received FDA Fast Track designation as competition intensifies to develop new narcolepsy treatments targeting sleep-wake regulation. Representative image.
Pharma & Biotech

Lundbeck has FDA Fast Track status for Lu AH69593, but can it catch the narcolepsy orexin leaders?

Lundbeck’s Lu AH69593 gains FDA Fast Track status, but its Phase 1 narcolepsy programme enters an increasingly competitive orexin field.

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Sentante’s CE-marked endovascular robotic platform combines catheter control, force sensing, medical imaging and procedural data capture to build a foundation for future physical AI-assisted vascular interventions. Representative image.
Medical Devices & Diagnostics

What Sentante’s physical AI strategy means for remote endovascular surgery in Europe

Sentante is using its CE-marked endovascular robot to capture force, motion and imaging data, but its clinical AI value still needs proof.

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A woman experiencing menopause-related fatigue and discomfort, as Bonerge Lifescience launches a clinical study evaluating EquoYouth S-equol for potential menopause symptom relief. Representative image.
Pharma & Biotech

Can Bonerge’s EquoYouth S-equol study strengthen evidence for menopause relief?

Bonerge Lifescience begins an EquoYouth S-equol menopause study as researchers test whether new data can strengthen a contested supplement case.

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Eli Lilly’s investigational retatrutide delivered significant weight loss and A1C improvements in the Phase 3 TRIUMPH-2 and TRIUMPH-3 obesity trials. Representative image.
Pharma & Biotech

Retatrutide TRIUMPH-3 trial advances Eli Lilly’s 2027 FDA filing plan

Eli Lilly’s retatrutide delivered up to 22.6% weight loss in two Phase 3 trials as a 2027 FDA filing moves closer.

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SimBioSys and Ferrum Health are expanding access to TumorSight Viz, an FDA-cleared AI platform designed to support breast cancer surgical planning using three-dimensional MRI visualisation. Representative image.
Medical Devices & Diagnostics

Can Ferrum Health solve the deployment bottleneck holding back SimBioSys’ TumorSight Viz?

SimBioSys and Ferrum Health bring FDA-cleared TumorSight Viz to Ferrum’s Model Hub, targeting scalable breast surgery AI deployment.

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A clinical laboratory processes a glycated albumin blood test as Precision Diabetes and Nagase Diagnostics pursue wider U.S. commercialization of the FDA-cleared Lucica Glycated Albumin-L assay for intermediate-term diabetes monitoring. Representative image.
Medical Devices & Diagnostics

What the Precision Diabetes and Nagase Diagnostics deal means for glycated albumin testing

Precision Diabetes and Nagase Diagnostics target wider U.S. access for Lucica, an FDA-cleared assay for two-to-three-week glycemic monitoring.

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Canton Strategic Holdings’ $3.5 million seller-financed sale of Gravitas Life Sciences separates its clinical-stage biotechnology pipeline from its Canton Network-focused digital asset strategy. Representative image.
Pharma & Biotech

Canton Strategic left biotech behind, but its $3.5m Gravitas deal is not a cash windfall

Canton Strategic sells Gravitas Life Sciences for a $3.5 million seller note, sharpening its Canton Network focus as biotech risks shift.

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Accord BioPharma’s U.S. launch of Osvyrti and Jubereq brings two interchangeable denosumab biosimilars into the increasingly competitive osteoporosis and oncology-support market. Representative image.
Pharma & Biotech

Jubereq launch: Accord BioPharma challenges Xgeva in cancer-related bone complications

Accord BioPharma launches Osvyrti and Jubereq as interchangeable denosumab biosimilars, testing price, payer access and provider adoption.

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A Phase 3 multiple myeloma research setting reflects Johnson & Johnson’s MonumenTAL-6 study, in which the Tecvayli-Talvey combination reportedly reduced the risk of disease progression or death by 89%. Representative image.
Pharma & Biotech

MonumenTAL-6 trial strengthens Johnson & Johnson’s dual-target multiple myeloma strategy

Johnson & Johnson’s Tecvayli-Talvey regimen cut progression risk by 89% in MonumenTAL-6. See what the topline data still must prove.

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