EMA reports big wins for small pharma

The success rate for marketing authorisation applications for small and medium-sized enterprises (SMEs) has doubled between 2016 and 2020, according to the European Medicines Agency (EMA). In 2016, 40% of medicines with an SME applicant received a positive opinion. In 2020, the number had increased to 89%. In 2020 alone, SMEs were behind 16 recommendations for approval of a new […]

Nefecon filed with EMA for primary IgA Nephropathy – Calliditas Therapeutics

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CHMP recommends approval of Klisyri for actinic keratosis – Almirall

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EMA validates MAA for Trodelvy under accelerated review in triple-negative breast cancer – Gilead Sciences

Copyright © ICR (UK) Limited t/a International Medical Information (IMI). Registered in the UK Company no. 05894351 medicalupdateonline.com is brought to you by International Medical Information. For more details, visit http://www.medicalimi.com Disclaimer: All information on this site has been collated by healthcare professionals from around the globe. Where every possible step has been taken to ensure its accuracy, MedicalUpdateOnline cannot […]

EMA validates MAA for relugolix for the treatment of advanced prostate cancer – Myovant Sciences

Copyright © ICR (UK) Limited t/a International Medical Information (IMI). Registered in the UK Company no. 05894351 medicalupdateonline.com is brought to you by International Medical Information. For more details, visit http://www.medicalimi.com Disclaimer: All information on this site has been collated by healthcare professionals from around the globe. Where every possible step has been taken to ensure its accuracy, MedicalUpdateOnline cannot […]