Meeting highlights from the Committee for Medicinal Products for Human ...
Jan 25, 2024 · EMA’s human medicines committee (CHMP) recommended three medicines for approval at its January 2024 meeting.
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.
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.
Pfizer Withdraws SCD Drug Oxbryta after EMA Discloses 16 Deaths …
Sep 26, 2024 · The EMA’s Committee for Medicinal Products for Human Use (CHMP) was set to discuss Oxbryta on Thursday at an “extraordinary meeting” convened for the purpose.
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 …
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.
EMA Committee for Medicinal Products for Human Use Adopts …
Sep 5, 2024 · Following the CHMP's positive opinion, the European Commission will make an authorization decision on the use of Moderna's updated COVID-19 vaccine for the autumn/winter season 2024-2025.
CHMP Adopts Positive Opinion Recommending Approval ...
Apr 26, 2024 · PRINCETON, N.J.-- (BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo® (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable o...
Meeting highlights from the Committee for Medicinal Products for Human ...
Jul 25, 2024 · EMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its July 2024 meeting. The CHMP recommended granting a marketing authorisation for Anzupgo (delgocitinib), a medicine intended for the treatment of moderate to severe chronic hand eczema in adults for whom topical corticosteroids are inadequate or inappropriate.
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...