Meeting highlights from the Committee for Medicinal Products for Human ...
4 days ago · EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its November 2024 meeting. The committee recommended granting a conditional marketing authorisation for Augtyro (repotrectinib), a medicine intended for the treatment of adults and adolescents with advanced solid tumours, and adults with locally advanced or ...
Meeting highlights from the Committee for Medicinal Products for Human ...
Oct 17, 2024 · News Human Medicines. Ten new medicines recommended for approval. The committee recommended granting a marketing authorisation for Alhemo (concizumab), a medicine for routine prophylaxis of bleeding in patients with haemophilia A or B with inhibitors, two types of a rare inherited bleeding disorder.
EMA human medicine committee recommends approval of …
2 days ago · The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for ...
Meeting highlights from the Committee for Medicinal Products for Human ...
Jun 27, 2024 · EMA’s human medicines committee (CHMP) recommended ten medicines for approval at its June 2024 meeting. The committee recommended granting a marketing authorisation for Balversa (erdafitinib), for the treatment of adult patients with unresectable or metastatic urothelial carcinoma, a cancer of the bladder and urinary system.
Committee for Medicinal Products for Human Use (CHMP)
Jun 20, 2024 · At the Committee for Medicinal Products for Human Use (CHMP)’s March meeting, twelve medicines received positive opinions for marketing authorisations, including a new antibiotic and a novel oral medicine for a rare blood disorder. news. CHMP issues positive option for first gene-editing medicine.
EMA Committee for Medicinal Products for Human Use Adopts …
Sep 5, 2024 · CAMBRIDGE, MA / ACCESSWIRE / September 5, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for an updated formulation of the COVID-19 mRNA vaccine Spikevax, targeting the SARS-CoV-...
Two Lung Cancer Drugs Recommended by EMA - Medscape
3 days ago · The regulatory body's Committee for Medicinal Products for Human Use (CHMP) supported granting a conditional marketing authorization for repotrectinib (Augtyro). The drug is intended for adults ...
EMA Committee for Medicinal Products for Human Use Adopts …
Sep 14, 2023 · CAMBRIDGE, MA / ACCESSWIRE / September 14, 2023 / Moderna, Inc. (Nasdaq:MRNA) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for Spikevax, its updated COVID-19 …
CHMP issues positive recommendation for approval of lecanemab …
4 days ago · STOCKHOLM, Nov. 14, 2024 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announces that EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive ...
EMA's Committee for Medicinal Products for Human Use (CHMP)
Jul 14, 2022 · At its July meeting, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended 11 medicines for approval and extended the indication of six more, including Imvanex for the prevention of monkeypox.
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