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 ...
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 ...
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 ...
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 ...
ots13d
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.
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 ...
EMA panel backs Bristol Myers' Opdivo-Yervoy for liver cancer
PRINCETON, N.J. - Bristol Myers Squibb (NYSE: BMY), a prominent pharmaceutical company with a market capitalization of nearly $120 billion and impressive gross profit margins of 76%, received a ...
Yahoo Finance21d
Lilly gains US FDA approval for Omvoh to treat Crohn’s disease
In December 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the therapy for approval in the EU to treat adults with moderately to se ...
Morningstar24d
Teva Announces Collaboration to Commercialize Formycon’s Biosimilar Candidate to Eylea® (aflibercept) in major parts of Europe and in Israel
In November 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for the marketing authorization of FYB203 under the ...
Financial Post24d
Teva Announces Collaboration to Commercialize Formycon's Biosimilar Candidate to Eylea® (aflibercept) in major parts of Europe and in Israel
In November 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for the marketing authorization of FYB203 under the brand ...