Ultragenyx receives PRIME designation from EMA for GTX-102 for the treatment of Angelman syndrome

5 February 2024 - GTX-102 is the first Angelman syndrome therapeutic candidate to receive PRIME designation. ...

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EMA accepts Valneva’s Chikungunya vaccine marketing authorisation application for accelerated assessment

27 November 2023 - Valneva today announced that the EMA has performed a technical validation of the marketing authorisation application ...

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Praxis Precision Medicines receives PRIME designation from the EMA for elsunersen (PRAX-222) for treatment of SCN2A gain of function developmental epilepsies

16 November 2023 - IRE) -- Praxis Precision Medicines today announced that the EMA has awarded its Priority Medicines (PRIME) designation ...

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Valneva submits Chikungunya vaccine marketing application to EMA and announces CHMP accelerated assessment

25 October 2023 - Valneva today announces the submission of a marketing application with the EMA for approval of the ...

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Annexon receives PRIME designation from the EMA for ANX007 for the treatment of geographic atrophy

24 October 2023 - PRIME designation granted based on Phase 2 ARCHER trial results, which showed meaningful preservation of visual function ...

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4DMT receives EMA Priority Medicines (PRIME) designation for 4D-150 clinical stage genetic medicine for treatment of wet AMD

23 October 2023 - 4D-150 combines a novel, targeted intravitreal next generation AAV vector with a dual transgene that inhibits four ...

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Intellia Therapeutics receives Priority Medicines (PRIME) designation from the EMA for NTLA-2002, an investigational in vivo CRISPR genome editing treatment for hereditary angioedema

13 October 2023 - Intellia Therapeutics today announced that the EMA has granted Priority Medicine (PRIME) designation to NTLA-2002 for ...

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Cellectar Biosciences receives European Medicines Agency Priority Medicines (PRIME) designation for iopofosine for Waldenstrom’s macroglobulinaemia

18 September 2023 - The EMA’s PRIME status is granted to drug candidates that may offer a major therapeutic advantage over ...

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Rocket Pharmaceuticals receives EMA Priority Medicines (PRIME) designation for RP-A501 gene therapy for Danon disease

31 May 2023 - Rocket Pharmaceuticals today announced that the EMA has granted Priority Medicines (PRIME) designation to RP-A501, the ...

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Genethon given PRIME status by EMA for gene therapy to treat Crigler-Najjar syndrome, a rare liver disease

7 March 2023 - Genethon today announced that the EMA has granted PRIME (Priority Medicines) status to the gene therapy, ...

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US FDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review

21 February 2023 - US FDA has set an action date for August 2023. ...

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Forge Biologics receives PRIME designation from the EMA for novel gene therapy FBX-101 for the treatment of patients with Krabbe disease

17 January 2023 - FBX-101 is granted priority medicines (PRIME) designation by the EMA after review of Phase 1/2 RESKUE clinical ...

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UCB announces rozanolixizumab BLA for the treatment of generalised myasthenia gravis filed with US FDA and designated for priority review

6 January 2023 - Biologic license application designated priority review by FDA and seeks approval for rozanolixizumab for the treatment ...

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Study: high concordance in breakthrough therapy, PRIME decisions

8 November 2022 - The US FDA and the EMA agreed on nearly two-thirds of decisions to grant or deny ...

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GSK marketing authorisation application for respiratory syncytial virus older adult vaccine candidate accepted by European Medicines Agency under accelerated assessment

28 October 2022 - Application based on positive pivotal Phase 3 data showing vaccine efficacy against respiratory syncytial virus-lower respiratory tract ...

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