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European Medicines Agency

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A representative image illustrating TNX-103 heart failure clinical research after Tenax Therapeutics’ Phase 3 LEVEL trial missed its primary exercise-capacity endpoint in pulmonary hypertension associated with heart failure with preserved ejection fraction.
Pharma & Biotech

Tenax heart failure drug fails Phase 3 test despite 49% drop in cardiac stress biomarker

TNX-103 misses its Phase 3 LEVEL endpoints as Tenax shares collapse. See why a 26.3-meter subgroup benefit could keep the program alive.

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Wearable devices are becoming clinical-trial tools for measuring digital endpoints such as heart rate, activity and sleep, but regulatory acceptance will depend on proving that these measurements are accurate, clinically meaningful and reliable across diverse patient populations. Representative image.
Features & Analysis

Smartwatches can collect millions of clinical-trial measurements. Regulators still need one question answered

Wearable devices are moving beyond step counts and wellness tracking to become clinical-trial instruments, but regulatory acceptance will depend on whether sponsors can prove that digital endpoints are accurate, meaningful and reliable across diverse patient populations.

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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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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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CSL’s positive Phase 3b ANDEMBRY results support planned regulatory filings for garadacimab-gxii in children aged 2 to 11 with hereditary angioedema. Representative image.
Pharma & Biotech

CSL plans expanded pediatric ANDEMBRY filing after positive garadacimab Phase 3b data

CSL’s pediatric ANDEMBRY data support filings in children aged 2 to 11, but regulators still need full safety, PK and efficacy results.

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Representative image: A retina specialist reviews advanced eye scans as Roche’s $RHHBY Susvimo moves closer to European approval, offering wet age-related macular degeneration patients a refillable implant designed to reduce frequent eye injections.
Pharma & Biotech

Roche gains positive CHMP opinion for Susvimo in wet age-related macular degeneration

Roche’s Susvimo wins a positive European opinion for wet AMD. See how two yearly refills could reduce injections and reshape retinal care.

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NewAmsterdam Pharma and Menarini Group have moved Ubeslo and Evlarco closer to European authorization after receiving a positive CHMP opinion for the obicetrapib cholesterol treatments, although final European Commission approval and cardiovascular outcomes data remain crucial. Representative image.
Pharma & Biotech

NewAmsterdam Pharma and Menarini receive positive CHMP opinion for Ubeslo and Evlarco

CHMP backs Ubeslo and Evlarco, moving obicetrapib closer to European authorization while PREVAIL tests cardiovascular outcomes.

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Enhertu plus pertuzumab has received CHMP backing as a potential first-line treatment for HER2-positive metastatic breast cancer, bringing the combination closer to European Union authorization. Representative image.
Pharma & Biotech

Why Enhertu’s EU recommendation could end a decade of stability in first-line HER2 breast cancer treatment

EU regulators back Enhertu plus pertuzumab for first-line HER2-positive metastatic breast cancer, shifting focus to approval, safety and access.

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