Meeting highlights from the Committee for Medicinal Products for Human ...
WEB2 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.
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 ...
WEBJan 25, 2024 · EMA’s human medicines committee (CHMP) recommended three medicines for approval at its January 2024 meeting.
DARZALEX ® (daratumumab)-based quadruplet regimen receives …
WEB1 day 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 …
Dupixent® (dupilumab) Recommended for EU Approval by the …
WEB22 hours 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 ...
Novo Secures EU Panel’s Backing for Cardiovascular Use of Wegovy
WEB21 hours 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 ...
AbbVie Receives Positive CHMP Opinion for Mirvetuximab
WEB23 hours 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 ...
EMA Broadens Imvanex Vaccine Use to Teens as Mpox Cases Rise
WEB1 day ago · September 20, 2024. 0. The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended extending the indication of the smallpox and mpox vaccine ...
EMA Committee for Medicinal Products for Human Use Adopts …
WEBSep 14, 2023 · EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Authorization of Moderna’s Updated Covid-19 Vaccine in The European Union. September 14, 2023. Download. The positive opinion follows the recommendation from regulators and global public health bodies to develop monovalent XBB.1.5 COVID-19 vaccines for ...