Browsing Tag
European Medicines Agency
91 posts
Takeda’s TAKHZYRO approved by EC for pediatric hereditary angioedema
Takeda has announced a significant advancement in the treatment of Hereditary Angioedema (HAE), with the European Commission’s approval…
EMA validates LEO Pharma’s application for delgocitinib cream in chronic hand eczema
LEO Pharma A/S said that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for…
Can-Fite submits pediatric plan to FDA for Piclidenoson in psoriasis treatment
Biotech leader Can-Fite BioPharma, known for its advances in oncology, inflammatory, and liver diseases, has taken a significant…
CHMP recommends approval for BeiGene’s tislelizumab in ESCC treatment
BeiGene, a global biotechnology firm, has revealed that the European Medicines Agency’s (EMA) Committee for Medicinal Products for…
CHMP endorses Merck’s gefapixant for EU approval for chronic cough treatment
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval for gefapixant,…
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…