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European Commission

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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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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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Representative image: A pediatric neurology consultation and brain MRI review illustrate leriglitazone’s positive European recommendation for boys with early-stage cerebral adrenoleukodystrophy.
Pharma & Biotech

Minoryx Therapeutics secures exceptional-circumstances CHMP recommendation for leriglitazone

Leriglitazone wins a positive European opinion for boys with early cerebral adrenoleukodystrophy after a narrower pediatric application.

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A patient receives infusion-based breast cancer care as clinicians review treatment imaging, reflecting the CHMP recommendation for Gilead Sciences’ Trodelvy plus Keytruda in first-line PD-L1-positive metastatic triple-negative breast cancer. Representative image.
Pharma & Biotech

Gilead’s Trodelvy cleared a key EU hurdle, but can it really replace chemotherapy in first-line TNBC?

CHMP backs Trodelvy plus Keytruda for first-line PD-L1-positive metastatic TNBC, moving Gilead closer to an expanded EU label.

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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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Allergan Aesthetics’ European approval for Boey introduces a rapid-onset, short-duration neurotoxin option for treating moderate to severe frown lines. Representative image.
Pharma & Biotech

Boey can show results in hours and fade in weeks: Why AbbVie is betting shorter can be better

AbbVie wins European approval for Boey, a rapid-onset neurotoxin lasting two to three weeks, opening a new test of aesthetics demand.

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Representative image: Tepkinly’s European approval expands bispecific antibody treatment options for adults with relapsed or refractory follicular lymphoma, potentially reshaping second-line lymphoma care.
Pharma & Biotech

Genmab and AbbVie secure EU approval for Tepkinly in relapsed follicular lymphoma

Discover how Tepkinly’s EU approval could reshape second-line follicular lymphoma treatment and the safety and access questions still ahead.

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Representative image: Enhertu’s EU tumor-agnostic approval highlights how HER2 testing and precision oncology diagnostics could shape treatment access for advanced solid tumors.
Medical Devices & Diagnostics

Enhertu wins EU tumor-agnostic approval, but HER2 testing will decide its real impact

The European approval takes Enhertu beyond organ-specific oncology, although its clinical reach will depend on reliable HER2 testing, reimbursement and safety management.

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