Browsing Tag
European Medicines Agency
91 posts
Janssen seeks expanded approval for DARZALEX in treating AL amyloidosis
Janssen Pharmaceutical Companies of Johnson & Johnson has recently submitted a Type II variation application to the European…
Gilead Sciences announces Veklury EU approval for COVID-19 treatment
Veklury EU approval : Gilead Sciences said that Veklury (remdesivir) has been given conditional marketing authorization from the…
Medivir gets orphan medicinal product designation for MIV-818 for HCC in EU
Swedish biotech company Medivir has secured orphan medicinal product designation from the European Commission for MIV-818 for the…
Sanofi, Regeneron secure Libtayo EMA approval for a type of skin cancer
Libtayo EMA approval : The European Commission has given conditional approval for Libtayo (cemiplimab) for the treatment of…
Alexion Pharmaceuticals secures FDA priority review for SOLIRIS in neuromyelitis optica spectrum disorder
Alexion Pharmaceuticals has secured a significant milestone with the FDA granting priority review for its C5 complement inhibitor,…
Biohaven secures orphan drug status for verdiperstat in MSA treatment
Connecticut-based Biohaven Pharmaceutical has received a significant regulatory boost, with the US FDA granting orphan drug designation for…
Pfizer, AbbVie settle global IP for Humira biosimilar, paving way for European launch
In a significant step towards expanding biosimilar access, Pfizer and AbbVie have resolved all global intellectual property disputes…
EC approves Pelmeg: Mundipharma’s answer to chemotherapy-induced neutropenia
Mundipharma, a German pharmaceutical company, has achieved a significant milestone with the European Commission (EC)’s approval of Pelmeg,…
Spark Therapeutics’ Luxturna gains EU approval as first gene therapy for inherited retinal disease
In a significant breakthrough for treating inherited vision loss, Pennsylvania-based Spark Therapeutics has received European Commission (EC) approval…
Novartis’ Sandoz gains EC approval for biosimilar Hyrimoz across multiple therapeutic areas
In a significant advancement for biopharmaceuticals, Novartis’ division Sandoz has secured approval from the European Commission (EC) for…