Page 60 - Human Use News Today

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of nivolumab monotherapy for the adjuvant treatment of patients at least 12 years of age with completely resected stage IIB or IIC melanoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of a Type II variation for teclistamab in the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior therapies.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended conditional marketing authorization of talquetamab for use as a single agent in adult patients with relapsed or refractory multiple myeloma who have previously received at least 3 therapies.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab plus trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of patients with advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors have a PD-L1 combined positive score of at least 1.

(RTTNews) - PTC Therapeutics, Inc. (PTCT) announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion for the...

Real-time index price for TSX Global Mining Index (TXGM), along with buy or sell indicators, analysis, charts, historical performance, news and more

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of JZP458 for use in combination with multi-agent chemotherapy for the treatment of adult and pediatric patients 1 month and older with acute lymphoblastic leukemia and lymphoblastic lymphoma who developed hypersensitivity or silent inactivation to Escherichia coli–derived asparaginase.

French drugmaker Ipsen said on Wednesday the European Commission has not granted marketing authorization for palovarotene, an investigational treatment for fibrodysplasia ossificans progressiva.

The biopharmaceutical company has been fighting in court for eight years to prove interference and a disequilibrium of power at the European Medicines Agency.

European Commission determines not to grant marketing authorization approval for palovarotene for fibrodysplasia ossificans progressiva Decision follows negative opinion by the Committee for Medicinal...