European regulators have recommended extending TRYNGOLZA to adults with fasting triglycerides of at least 880 mg/dL. The decision follows two Phase 3 trials demonstrating substantial triglyceride reductions and 85% fewer adjudicated acute pancreatitis events in a pooled analysis.
The EMA's CHMP has maintained its negative opinion on narsoplimab for transplant-associated thrombotic microangiopathy, citing unresolved clinical evidence concerns. Omeros disputes aspects of the re-examination and is shifting attention toward US commercialization and alternative patient access arrangements.
Find out how Enhertu’s EU recommendation could reshape HER2 targeted treatment for metastatic solid tumors.
Gilead’s Trodelvy may move earlier in metastatic TNBC. The EU signal could reshape first-line ADC use, but adoption questions remain.
Merck’s bladder cancer push is moving earlier in Europe. KEYTRUDA plus Padcev could reset cisplatin-ineligible MIBC care.
Plozasiran clears CHMP but the real test is reimbursement. Europe's HTA bodies will now decide whether clinical FCS diagnosis is enough.
Novartis Pharma AG’s Itvisma gains CHMP support in SMA. Find out how gene therapy could reshape treatment for older patients in Europe.
CHMP backs CAMCEVI 21 mg for advanced prostate cancer in the EU. Discover what the decision means for androgen deprivation therapy and oncology markets.
Acadia seeks EU re-examination after CHMP rejects trofinetide for Rett syndrome. Read the regulatory and clinical implications.
Ipsen nears EU approval for Ojemda in BRAF-driven pediatric glioma. Explore regulatory impact, clinical implications, and long-term risks.