Browsing Tag
European Medicines Agency
66 posts
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…
AstraZeneca’s Imfinzi garners positive opinion from CHMP for NSCLC treatment
AstraZeneca has reached a crucial milestone as the Committee for Medicinal Products for Human Use (CHMP) of the…