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European Commission

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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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Representative image: An oncologist reviews lung scan images in a modern cancer care setting, reflecting Amgen’s EU approval for Imdylltra in relapsed extensive-stage small cell lung cancer.
Pharma & Biotech

Why Amgen’s Imdylltra EU approval could reshape second-line small cell lung cancer treatment

Find out how Amgen’s Imdylltra EU approval could change relapsed small cell lung cancer treatment across Europe.

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Representative image of an oncologist reviewing lung cancer scans in a modern treatment room, reflecting Amgen’s European approval for Imdylltra and the growing shift toward bispecific antibody therapies for extensive-stage small cell lung cancer.
Pharma & Biotech

Is Amgen’s bispecific lung cancer drug becoming a global standard after chemotherapy failure?

Amgen’s Imdylltra has European approval in relapsed small cell lung cancer. Survival data now face reimbursement and adoption tests.

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Representative image: A clinician reviews bladder cancer imaging in a modern oncology setting, reflecting Merck’s KEYTRUDA plus Padcev EU regulatory milestone for cisplatin-ineligible muscle-invasive bladder cancer patients.
Pharma & Biotech

Why Merck’s CHMP win for KEYTRUDA plus Padcev matters in muscle-invasive bladder cancer

Merck’s bladder cancer push is moving earlier in Europe. KEYTRUDA plus Padcev could reset cisplatin-ineligible MIBC care.

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Representative image: A haematology consultation illustrates how PYRUKYND’s European Union approval for adults with thalassaemia could shift attention toward oral rare blood disease treatments, patient access and reimbursement across Europe.
Pharma & Biotech

Could Agios and Avanzanite turn PYRUKYND into Europe’s next rare blood disease launch test?

PYRUKYND has EU approval in thalassaemia. Now Agios and Avanzanite face Europe’s harder test: access, uptake and reimbursement.

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