Tag: European Medicines Agency
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 Agency's (EMA) Committee for Medicinal Products for ... Read More
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) for CARVYKTI (ciltacabtagene autoleucel or cilta-cel), based ... Read More
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 with facial involvement in adults and adolescents, ... Read More
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) for the treatment of primary IgA nephropathy ... Read More
Merck seeks FDA and EMA approvals for V114 pneumococcal conjugate vaccine candidate
V114 pneumococcal conjugate vaccine candidate : Merck has submitted applications to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval ... Read More
Janssen seeks EMA’s expanded approval for DARZALEX in AL amyloidosis
The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a Type II variation application to the European Medicines Agency (EMA) seeking the expanded approval ... Read More
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 European Commission as a treatment for SARS-CoV-2 ... Read More
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 treatment of hepatocellular carcinoma (HCC). The orphan ... Read More
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 adult patients with metastatic or locally advanced ... Read More
Spark Therapeutics bags Luxturna EU approval for inherited retinal disease
Luxturna EU approval for inherited retinal disease : Pennsylvania-based Spark Therapeutics has bagged the European Commission’s (EC) approval for its gene therapy Luxturna (voretigene neparvovec) ... Read More