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NEWS

Neurona Therapeutics’ NRTX-1001 Secures the EMA’s Priority Medicines (PRIME) Designation for Drug-Resistant Focal Epilepsy

Shots: The EMA has granted PRIME designation to NRTX-1001 for adults with drug-resistant focal epilepsy, based on preclinical & emerging clinical data NRTX-1001 is also being evaluated in 2 ongoing P-I/II trials for drug-resistant unilateral & bilateral mesial temporal lobe epilepsy (MTLE), with P-III (EPIC) trial planned to begin in H2’25 for drug-resistant MTLE The…
November 6, 2025

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New Drug Designations: July 2025
INSIGHTS+

New Drug Designations: July 2025

Shots:       PharmaShots’ Designation Report offers a concise overview of the latest drug and device designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA.    The July 2025 edition covers designations awarded to 47 drugs and 3 medical devices, comprising 23 small molecules, 9 biologics, 8 cell and gene therapies, and…
August 26, 2025

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NEWS

BeOne Medicines’ BGB-16673 Receives the EMA’s PRIME Designation to Treat Waldenstrom’s Macroglobulinemia

Shots: The EMA has granted PRIority MEdicines (PRIME) designation to BGB-16673 for the treatment of pts with Waldenstrom’s macroglobulinemia (WM), who previously were treated with a BTK inhibitor Designation was based on data showing BGB-16673’s novel ability to degrade both wild-type & mutant BTK forms, incl. resistance-linked variants, which demonstrated anti-tumor activity in B-cell malignancies…
August 1, 2025

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