Meeting highlights from the Committee for Medicinal Products for Human ...
WEB3 days ago · EMA’s human medicines committee elects new Chair. 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.
Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron …
WEB2 days ago · The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has completed its rigorous evaluation of COMIRNATY, concluding by consensus that sufficiently ...
Meeting highlights from the Committee for Medicinal Products for Human ...
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.
Meeting highlights from the Committee for Medicinal Products for Human ...
WEBJul 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 …
Dupixent® (dupilumab) Recommended for EU Approval by the …
WEB2 days ago · --Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the European Medicines Agency’ s Committee for Medicinal Products for Human Use adopted a positive opinion recommending the ...
DARZALEX ® (daratumumab)-based quadruplet regimen receives …
WEB2 days ago · BEERSE, BELGIUM (20 September 2024) – Janssen-Cilag International NV, a Johnson & Johnson company, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a Type II variation for DARZALEX ® (daratumumab) subcutaneous (SC) formulation. The recommendation is for daratumumab SC in …
Pfizer Receives Positive CHMP Opinion for Conversion of …
WEBNew 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 …
AbbVie Receives Positive CHMP Opinion for Mirvetuximab
WEB2 days 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 ...
Novo Nordisk A/S: Wegovy® recommended by the European
WEB2 days ago · Bagsværd, Denmark, 19 September 2024 – Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive ...
Novo Secures EU Panel’s Backing for Cardiovascular Use of Wegovy
WEB2 days ago · Thursday’s positive opinion from the Committee for Medicinal Products for Human Use (CHMP) will help guide the European Commission (EC) in delivering its final verdict on the matter. Novo is confident that the review will come out in the company’s favor, noting in its announcement that the company “expects implementation of the EU label ...