AstraZeneca’s Calquence recommended for approval in EU for treatment of MCL
Calquence in combination with bendamustine and rituximab has been recommended for approval in the European Union, EU, for ...
PharmiWeb7h
Moderna Receives Medicines and Healthcare Products Regulatory Agency Marketing Authorization in the UK for RSV Vaccine
Moderna, Inc. (NASDAQ:MRNA) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has granted marketing authorization for mRESVIA (mRNA-1345), indicated for ...
PharmiWeb7h
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 ...
European Medicines Agency (EMA) Validates Henlius And Organon Filing For Perjeta® (Pertuzumab) Biosimilar Candidate HLX1...
Shanghai Henlius Biotech, Inc. (2696) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has valida ...
Donald Trump plans to tariff a key product imported from Ireland, but the tiny European nation is taking him head-on; here's how
President Trump's proposed tariffs on Irish pharmaceutical imports aim to boost US production but may ultimately harm ...
Eli Lilly’s (LLY) Alzheimer’s Drug Is Rejected in Europe Over Safety Fears
A European health committee has rejected Eli Lilly’s Alzheimer’s drug, Kisunla, because of safety concerns about possible ...
precisionmedicineonline3d
EMA's CHMP Recommends Against Approval of Eli Lilly's Alzheimer's Drug Kisunla in Europe
NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Thursday recommended against marketing authorization for Eli Llilly's Alzheimer's drug Kisunla ...
Fierce Pharma3d
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 ...
European Commission Declines To Renew Marketing Authorization Of Translarna Duchenne Muscular Disorder
PTC Therapeutics' Translarna loses EU conditional approval, but countries may allow continued use. PTC submitted four FDA ...
STAT3d
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 ...
Indianapolis Business Journal3d
European regulators says Lilly Alzheimer’s drug shouldn’t get marketing approval
The European Medicines Agency committee said the benefits of the new drug, Kisunla, did not outweigh the risks, and it ...