PMLive2h
Johnson & Johnson’s Tremfya recommended by CHMP to treat Crohn’s disease
Johnson & Johnson (J&J) has announced that its Tremfya (guselkumab) has been recommended by the European Medicines Agency’s ...
BeiGene Receives Positive CHMP Opinion for TEVIMBRA® as a First-Line Treatment for Extensive-Stage Small Cell Lung Cancer
BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced that the Committee for Medicinal Products for ...
STAT2d
Eli Lilly’s Alzheimer’s drug gets thumbs-down from European regulators
Eli Lilly's Kisunla was approved in the U.S. for Alzheimer's last year, but now advisers to the European Medicines Agency say ...
European committee says Lilly Alzheimer's drug shouldn't get marketing approval
A European regulatory committee rejected Eli Lilly’s U.S.-approved Alzheimer’s disease treatment over potentially dangerous ...
Fierce Pharma2d
Eli Lilly's Alzheimer's contender Kisunla gets thumbs down from EU regulators over safety concerns
After failing to pass muster with England’s drug reimbursement watchdog earlier this month, Eli Lilly’s Alzheimer’s disease ...
Bristol Myers announces CHMP recommendation for Opdivo formulation approval
Bristol Myers (BMY) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval ...
Eli Lilly to seek re-examination by CHMP of opinion to not recommend donanemab
The European Medicines Agency’s Committee for Medicinal Products for Human Use issued an opinion that does not recommend Eli Lilly (LLY) and ...
PharmiWeb3h
Calquence plus chemoimmunotherapy recommended for approval in the EU by CHMP as first and only BTK inhibitor for 1st-line mantle cell lymphoma
AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab has been recommended for approval in the European Union (EU) for the treatment of adult patients with previously ...
Medscape2d
Benefits Outweigh Risks for Weight Loss Drug Mysimba
The benefits of naltrexone/bupropion (Mysimba) continue to outweigh its risks, despite ongoing uncertainty about long-term ...
Nasdaq1mon
The Committee for Medicinal Products for Human Use (CHMP) Reaffirms Positive Opinion for Lecanemab in Early Alzheimer's Disease
TOKYO and CAMBRIDGE, Mass., Feb. 28, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate ...
abc271mon
The Committee for Medicinal Products for Human Use (CHMP) reaffirms positive opinion for Lecanemab in early Alzheimer's disease in the EU
STOCKHOLM, Feb. 28, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced today that the Committee for Medicinal Products for Human Use (CHMP) of ...