The Priority Review

Tag

CHMP

2 stories

  1. Approvals

    CHMP recommends marketing authorisation for Neuzafy

    On 15 October 2026 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Neuzafy, a filgrastim biosimilar. The applicant is CuraTeQ Biologics (Malta) Limited and Neuzafy will be available as 30 MU/0.5 ml and 48 MU/0.5 ml solutions for injection/infusion.

  2. Approvals

    CHMP adopts positive opinion on Rasonque for metastatic pancreatic cancer

    The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on 15 October 2026, recommending marketing authorisation for Rasonque, a daraxonrasib monotherapy for adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy. The product will be available as 100 mg and 150 mg film-coated tablets and is designated as an orphan medicine.