Meeting highlights from the Committee for Medicinal Products for Human ...
Oct 17, 2024 · The Committee for Human Medicinal Products (CHMP) elected Outi Mäki-Ikola as its new vice-chair for a three-year mandate, starting on 15 October 2024. A medical doctor by training, with a PhD in immunology, Dr Mäki-Ikola has …
Meeting highlights from the Committee for Medicinal Products for Human ...
Jan 25, 2024 · Three new medicines recommended for approval. EMA’s human medicines committee (CHMP) recommended three medicines for approval at its January 2024 meeting. The committee recommended granting a marketing authorisation for Exblifep (cefepime/enmetazobactam), for the treatment of complicated urinary tract infections, including pyelonephritis ...
Committee for Medicinal Products for Human Use (CHMP)
The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency's (EMA) committee responsible for human medicines. It plays a vital role in the authorisation of medicines in the European Union. The committee meets once a month. EMA publishes agendas, minutes and highlights of its plenary meetings.
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 ...
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 (CHMP)
Mar 2, 2023 · In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended several new medicines, including positive opinions for treatments for rare disorders. news Positive CHMP recommendation for antibiotic combination
EMA's Committee for Medicinal Products for Human Use (CHMP)
May 24, 2020 · 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 …
Jul 23, 2021 · CAMBRIDGE, Mass.-- ( BUSINESS WIRE )-- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Medicines...
EMA Committee for Medicinal Products for Human Use Adopts …
Sep 5, 2024 · The CHMP decision is based on a combination of manufacturing and preclinical data, as well as previous clinical, non-clinical, and real-world evidence supporting the efficacy and safety of Moderna's COVID-19 mRNA vaccines.
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.