Medscape5d
EMA to Review New Safety Data on Alzheimer’s Drug Leqembi
The reassessment of Leqembi’s safety data follows the agency’s previous recommendation of the drug for use in the EU.
Yahoo Finance13d
X4 Pharmaceuticals Announces EMA Validation of Marketing Authorization Application (MAA) for Mavorixafor for the Treatment of WHIM Syndrome
has been validated for review and is now under evaluation with the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The EMA previously granted orphan ...
X4 Pharmaceuticals announces EMA validation of MAA for mavorixafor
X4 Pharmaceuticals (XFOR) announced that its Marketing Authorization Application for mavorixafor for the treatment of WHIM syndrome, a rare ...
AstraZeneca’s Imfinzi recommended for approval in EU by CHMP
Imfinzi has been recommended for approval in the European Union, EU, as monotherapy for the treatment of adults with ...
Medscape6d
EMA Expedites Adolescent Chikungunya Vaccine Recommendation
In its first meeting of 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) gave the green light for the first vaccine in the EU to protect adolescents ...
Yahoo Finance12d
X4 Pharmaceuticals Announces EMA Validation of Marketing Authorization Application (MAA) for Mavorixafor for the Treatment of WHIM Syndrome
has been validated for review and is now under evaluation with the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The EMA previously granted orphan ...
ots12d
X4 Pharmaceuticals Announces EMA Validation of Marketing Authorization Application (MAA) for Mavorixafor - licenced to Norgine for commerc
has been validated for review and is now under evaluation with the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). In April 2024, mavorixafor received U.S.
Pharmabiz9d
EMA validates X4 Pharma’s marketing authorization application for mavorixafor to treat WHIM syndrome
has been validated for review and is now under evaluation with the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The EMA previously granted orphan ...
Nasdaq12d
X4 Pharmaceuticals' Mavorixafor MAA for WHIM Syndrome Validated by EMA Following US Approval
has been validated for review and is now under evaluation with the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The EMA previously granted orphan ...
pharmaphorum21d
Takeda dengue vaccine receives positive CHMP opinion
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of Takeda GmbH’s live, attenuated dengue tetravalent vaccine, Qdenga (TAK ...