Browsing Tag
European Medicines Agency
66 posts
Menarini’s ORSERDU gets CHMP positive opinion in advanced breast cancer
The Menarini Group and its subsidiary, Stemline Therapeutics Inc., have received a favorable opinion from the European Medicines…
Legend Biotech announces submission of CARVYKTI application to EMA for multiple myeloma
Legend Biotech has announced the submission of a Type II variation application to the European Medicines Agency (EMA)…
Incyte bags Opzelura EC approval for treatment of non-segmental vitiligo
Incyte has secured marketing authorization for Opzelura (ruxolitinib) cream 15mg/g from the European Commission (EC) for non-segmental vitiligo…
Chinook Therapeutics gets orphan drug status from EC for atrasentan in IgAN
Chinook Therapeutics, a US-based biopharma company, has secured orphan drug designation for atrasentan from the European Commission (EC)…
Merck seeks FDA and EMA approvals for V114 pneumococcal conjugate vaccine candidate
Merck & Co., a global leader in pharmaceutical development, has submitted applications to the US Food and Drug…
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,…