Meeting highlights from the Committee for Medicinal Products for …
WEB3 days ago · The Committee for Human Medicinal Products (CHMP) elected Bruno Sepodes as its new chair. Professor Sepodes starts his three-year mandate on 21 September and succeeds Dr Harald Enzmann as chair, who completed the maximum two three-year terms allowed for CHMP chairs. More …
Committee for Medicinal Products for Human Use (CHMP)
WEBThe 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.
Meeting highlights from the - European Medicines Agency (EMA)
WEBJun 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.
Europe's CHMP turns down Apellis' pegcetacoplan appeal, …
WEB1 day ago · The CHMP initially snubbed the drug in January and then again in June. Apellis has spent much of the year appealing the agency’s decisions. ... Ipsen also received good news from European ...
Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron …
WEB2 days ago · The CHMP recommendation dated September 19, 2024, is based on the non-clinical and manufacturing data of the Omicron KP.2-adapted vaccine and the clinical and real-world evidence supporting the ...
Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron …
WEB2 days ago · NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the companies’ Omicron KP.2-adapted monovalent COVID-19 vaccine (COMIRNATY ® KP.2) for active ...
AbbVie Receives Positive CHMP Opinion for Mirvetuximab
WEB1 day ago · NORTH CHICAGO, Ill., Sept. 20, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted ...
J&J gets CHMP nod for Rybrevant in first-line lung cancer
WEB2 days ago · The CHMP has recommended Rybrevant (amivantamab) for use alongside carboplatin and pemetrexed chemotherapy as a first-line treatment for advanced non-small cell lung cancer (NSCLC) with EGFR...
Dupixent® (dupilumab) Recommended for EU Approval by the CHMP …
WEB2 days ago · The positive CHMP opinion is supported by a two-part (Part A and B) EoE KIDS Phase 3 trial in children aged 1 to 11 years. In Part A, a significantly greater proportion of children receiving ...
MRNA Gets Positive CHMP Opinion for Updated COVID-19 Jab
WEBSep 6, 2024 · Moderna, Inc. MRNA announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency's (EMA) has rendered a positive opinion recommending marketing...