Meeting highlights from the Committee for Medicinal Products for Human ...
5 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 ...
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 ...
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.
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 ...
Committee for Medicinal Products for Human Use (CHMP)
Jun 20, 2024 · In its September 2023 meeting, the EMA’s human medicines committee (CHMP) recommended nine medicines for approval and the extension of therapeutic indications for 11 medicines. news CHMP recommends updated Omicron vaccine
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 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.
Pfizer Receives Positive CHMP Opinion for Conversion of …
New York, NY, January 27, 2023 – Pfizer Inc. (NYSE: PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended converting the conditional Marketing Authorization (cMA) for PAXLOVID TM (nirmatrelvir tablets and ritonavir tablets) to standard (also referred to as ...
Meeting highlights from the Committee for Medicinal Products for Human ...
Apr 25, 2024 · EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its April 2024 meeting. The CHMP recommended granting a marketing authorisation for Altuvoct* (efanesoctocog alfa), for the treatment and prophylaxis of bleeding in patients with haemophilia A, a rare inherited bleeding disorder caused by lack of factor VIII.
CHMP Recommends 14 Medicines for Approval at July Meeting
Jul 26, 2024 · At its meeting held July 22–25, 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave positive opinions or granted marketing authorizations to 14 medicines, EMA said in a press release issued July 26 (1).