Why EMA orphan status gives Zai Lab’s zoci more than a regulatory credibility boost
Find out how Zai Lab’s zocilurtatug pelitecan could reshape DLL3-targeted cancer therapy as development risks remain.
Pharma & Biotech
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.
Pharma & Biotech
Ribo’s coronary artery disease filing highlights the next frontier for RNA-based cardiovascular drugs
Ribo’s RBD1119 Phase 2 filing could test whether siRNA drugs can reduce coronary artery disease risk without bleeding trade-offs.
Pharma & Biotech
Enhertu nears wider EU approval as HER2 testing moves deeper into solid tumor oncology
Find out how Enhertu’s EU recommendation could reshape HER2 targeted treatment for metastatic solid tumors.
Pharma & Biotech
Gilead’s Trodelvy gains EU regulatory momentum, but the first-line TNBC fight is only beginning
Gilead’s Trodelvy may move earlier in metastatic TNBC. The EU signal could reshape first-line ADC use, but adoption questions remain.
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.
Features & Analysis
Why clinical biomarkers face a slow climb before regulators accept them as surrogate endpoints
Biomarkers can speed drug approvals, but weak validation can haunt sponsors. FDA and EMA are tightening the path from signal to endpoint.
Pharma & Biotech
EU backs Pfizer’s Hympavzi for hemophilia patients with inhibitors. What changes now?
Hemophilia care is moving beyond factor replacement. Pfizer’s Hympavzi EU expansion tests how far anti-TFPI therapy can scale.
Medical Devices & Diagnostics
Can Lasix ONYU move heart failure edema care from hospital infusion to home treatment?
Heart failure care needs fewer hospital stays. Lasix ONYU now tests whether Europe is ready for at-home subcutaneous diuresis.
Pharma & Biotech
Arrowhead’s plozasiran clears CHMP: what a positive opinion for FCS means for siRNA’s regulatory arc in Europe
Plozasiran clears CHMP but the real test is reimbursement. Europe's HTA bodies will now decide whether clinical FCS diagnosis is enough.