CHMP Endorses AstraZeneca's Fasenra in Rare Autoimmune Disease
WEB5 hours ago · AZN announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approving the regulatory filing seeking label expansion in the EU for its blockbuster asthma drug ...
Regeneron, SNY's Dupixent Get CHMP Recommendation for Label …
WEB1 day ago · The CHMP recommended the label expansion of Dupixent in the European Union (EU) for eosinophilic esophagitis (EoE) in children down to 1 year of age. The recommendation is for children aged 1 to ...
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.
Europe's CHMP turns down Apellis' pegcetacoplan appeal, …
WEB4 days 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 ...
MRK Gets Positive CHMP Nod for Keytruda in Two Gynecologic …
WEB1 day ago · MRK. Merck & Co., Inc. MRK 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 ...
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.
Meeting highlights from the Committee for Medicinal Products for …
WEBMar 21, 2024 · EMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its March 2024 meeting. The CHMP recommended granting a marketing authorisation for Awiqli (insulin icodec) for the treatment of diabetes mellitus in adults.
Pfizer and BioNTech Receive Positive CHMP Opinion for …
WEBNov 25, 2021 · The Phase 2/3 trial showed a favorable safety profile, robust immune responses and a vaccine efficacy rate of 90.7% in participants without prior SARS-CoV-2 infection, measured from 7 days after the second dose, during a period when Delta was the prevalant strain.
Press Release: Dupixent recommended for EU approval by the CHMP …
WEB4 days ago · Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old . Recommendation based on a phase 3 study showing a significantly greater ...
AbbVie Receives Positive CHMP Opinion for Mirvetuximab …
WEB4 days ago · The CHMP's opinion is supported by results of the Phase 3 MIRASOL clinical trial and the European Commission decision on this indication for mirvetuximab soravtansine is anticipated later this year.