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Purespring Therapeutics granted European Medicines Agency (EMA) orphan drug designation for PS-002 for the treatment of patients with primary IgA nephropathy (IgAN)
28 Apr 2025 06:00 GMT
… diseases, today announces that the European Medicines Agency (EMA) has granted orphan drug …
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Dyne Therapeutics Receives European Medicines Agency (EMA) Orphan Drug Designation for DYNE-251 in Duchenne Muscular Dystrophy
24 Apr 2025 11:30 GMT
- Recently presented data demonstrated sustained functional improvement with DYNE-251 treatment through 18 months - - Data from the fully enrolled DELIVER registrational expansion cohort is planned for late 2025 - WALTHAM, Mass., April 24, 2025 (GLOBE …
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Madrigal to Present Late-Breaking Resmetirom Data in Patients with Compensated MASH Cirrhosis at the EASL Congress
29 Apr 2025 12:00 GMT
… is under evaluation with the European Medicines Agency’s (EMA) Committee for Medicinal …
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Regeneron’s bispecific antibody Lynozyfic approved by EC to treat multiple myeloma
29 Apr 2025 11:43 GMT
… a recent recommendation from the European Medicines Agency’s human medicines committee and …
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Takeda receives CHMP recommendation for Adcetris in Hodgkin lymphoma
29 Apr 2025 11:43 GMT
… a new recommendation from the European Medicines Agency’s human medicines committee for …
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Prilenia and Ferrer to commercialise pridopidine in Europe
29 Apr 2025 10:15 GMT
… authorisation application (MAA) with the European Medicines Agency (EMA) for the approval of …
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EMA grants orphan drug status to Purespring’s IgA nephropathy treatment
29 Apr 2025 10:33 GMT
The European Medicines Agency (EMA) has granted orphan drug …
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Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
29 Apr 2025 11:13 GMT
… comes two months after the European Medicines Agency (EMA)’s Committee for Medicinal …
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Biohaven secures $600m financing as it awaits FDA prodrug decision
29 Apr 2025 11:13 GMT
… uncertain. Earlier in April, the European Medicines Agency (EMA) questioned whether the drug …
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BrainStorm's NurOwn® Data Selected as Breakthrough Science for Presentation at ISCT 2025 Meeting
29 Apr 2025 11:14 GMT
… Drug Administration (FDA) and the European Medicines Agency (EMA). A Phase 3 trial …