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RecovryAI is evaluating its clinical AI Virtual Care Assistant for monitoring patients after hip and knee replacement surgery as it prepares for a planned FDA De Novo filing. Representative image.
Medical Devices & Diagnostics

Can RecovryAI’s Virtual Care Assistant secure FDA De Novo authorization?

RecovryAI completes a 525-patient pivotal study phase as it prepares an FDA De Novo filing for postoperative clinical AI.

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Fresenius Kabi’s PB016 vedolizumab biosimilar has entered FDA and EMA review, advancing a potential Entyvio competitor for ulcerative colitis and Crohn’s disease. Representative image.
Pharma & Biotech

What Fresenius Kabi’s PB016 regulatory filings mean for the Entyvio biosimilar market

Fresenius advances PB016 into FDA and EMA review, but competition, manufacturing scrutiny and IV-only positioning will shape its launch path.

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Researchers assess clinical data and overlooked drug-development opportunities as Lōkahi Therapeutics expands its ai² Futures Lab to build a capital-efficient biopharma pipeline. Representative image.
Pharma & Biotech

Glucotrack expands Lōkahi Therapeutics ai² Futures Lab to 12 universities

Lōkahi Therapeutics screened 45-plus drug assets for $33,000. Can its university model turn overlooked programs into pipeline deals?

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Meitheal Pharmaceuticals’ FDA approval of Garzulys insulin aspart-fsan adds a new biosimilar option to the U.S. rapid-acting insulin market, sharpening competition around pricing, patient access and reliable supply. Representative image.
Pharma & Biotech

Meitheal has FDA approval for Garzulys, but can it break into America’s crowded mealtime insulin market?

FDA approval moves Meitheal’s Garzulys into the U.S. insulin aspart market, where pricing, supply and formulary access will decide uptake.

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One Biosciences’ FFPE single-cell tumour profiling research highlights how routine pathology samples could support deeper analysis of cancer cells, immune populations and the tumour microenvironment across multiple cancer types. Representative image.
Medical Devices & Diagnostics

Can One Biosciences bring single-cell transcriptomics into routine cancer pathology?

One Biosciences reports an FFPE single-cell workflow across six cancers, but clinical utility and prospective validation remain the next tests.

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Moyom’s Aphranel European expansion strategy combines EU MDR certification with Expert2Expert-led research, clinical education and physician training in regenerative aesthetics. Representative image.
Medical Devices & Diagnostics

What does Aphranel EU MDR certification mean for Moyom’s European expansion?

Moyom links Aphranel EU MDR certification with Expert2Expert research and training as it prepares for European regenerative aesthetics expansion.

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Polpharma Biologics’ PB016 vedolizumab biosimilar has entered regulatory review with the United States Food and Drug Administration and European Medicines Agency, advancing a potential new competitor to Takeda Pharmaceutical Company’s Entyvio for ulcerative colitis and Crohn’s disease. Representative image.
Pharma & Biotech

PB016 versus Entyvio: Polpharma Biologics joins the emerging vedolizumab biosimilar race

Polpharma Biologics’ PB016 enters FDA and EMA review, adding a new vedolizumab biosimilar challenge to Takeda’s Entyvio franchise.

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Datroway’s European Union approval expands first-line treatment options for patients with unresectable or metastatic triple-negative breast cancer who are not candidates for immunotherapy, following an overall survival benefit in the Phase 3 TROPION-Breast02 trial. Representative image.
Pharma & Biotech

Datroway EU approval expands first-line treatment options for metastatic triple-negative breast cancer

EU approval moves Datroway into first-line metastatic TNBC after TROPION-Breast02 showed survival gains, intensifying the TROP2 ADC race.

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IMPACT Therapeutics’ senaparib licensing agreement with Pharmanovia could expand the ovarian cancer therapy’s commercial reach across Europe, the Middle East, Africa, Australia and New Zealand. Representative image.
Pharma & Biotech

IMPACT Therapeutics expands senaparib globally through 66-country Pharmanovia licence

See how IMPACT Therapeutics’ €423.5 million senaparib deal with Pharmanovia could shape its European ovarian cancer launch.

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Representative image: Researchers prepare a personalized cancer cell therapy as Diakonos Oncology begins testing DOC1021 in patients with refractory melanoma that progressed after anti-PD-1 immunotherapy.
Pharma & Biotech

First DOC1021 patients treated in Phase 1/2 refractory melanoma trial

DOC1021 enters a Phase 1/2 refractory melanoma trial testing personalised dendritic cell therapy without lymphodepletion or high-dose IL-2

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