Johnson & Johnson secures EC approval for AKEEGA® as the first precision-medicine combo for BRCA1/2-mutated metastatic hormone-sensitive prostate cancer, supported by landmark rPFS data from the AMPLITUDE trial.
Johnson & Johnson announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending [Read More…]
Johnson & Johnson has secured European Commission approval for Imaavy (nipocalimab), a novel treatment for generalized myasthenia gravis (gMG). This authorization marks the first FcRn blocker approved in Europe for a broad population that includes both adults and adolescents (aged 12+), offering a new option for sustained disease control.
The European Commission has officially approved AstraZeneca’s Tezspire (tezepelumab) for adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP). This new add-on therapy offers hope for patients whose condition is uncontrolled by standard treatments, demonstrating efficacy in reducing polyp size, alleviating congestion, and decreasing the need for surgery.
Eli Lilly and Company announced the European Commission has granted marketing authorization for Kisunla (donanemab) to treat early symptomatic Alzheimer’s disease. The therapy demonstrated a significant slowing of cognitive and functional decline and is unique for supporting a finite treatment course.
Novo Nordisk reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a favorable opinion, suggesting that [Read More…]
AstraZeneca’s Calquence-based fixed-duration regimens gain EU approval for treating first-line CLL, offering patients a powerful, time-limited alternative to traditional continuous therapy.
GSK’s Blenrep combinations have received a positive opinion from the CHMP for treating relapsed/refractory multiple myeloma, backed by strong Phase III trial results showing improved survival outcomes.
Eli Lilly and Company’s (LLY) donanemab is not recommended for marketing authorization for the treatment of early symptomatic Alzheimer’s disease, according to an opinion released [Read More…]
The European Commission is currently taking final action on the application for the use of Jaypirca in patients with relapsed or refractory CLL who have received prior treatment with a BTK inhibitor as a result of this favorable view.
