Blog
RSS FeedPosted by Michael Wonder on 02 Mar 2025
Authorisations of human medicinal products with a new active substance and additional indications 2024
28 February 2025 - 46 human medicinal products with new active substances authorised. ...
Posted by Michael Wonder on 02 Mar 2025
Highlights from the 24-27 February 2025 CHMP meeting
28 February 2025 - Four new medicines recommended for approval; another 16 medicines recommended for extension of their therapeutic indications. ...
Posted by Michael Wonder on 02 Mar 2025
Krystal Biotech receives positive CHMP opinion for Vyjuvek for the treatment of dystrophic epidermolysis bullosa
28 February 2025 - EC approval decision anticipated in second quarter of 2025. ...
Posted by Michael Wonder on 02 Mar 2025
Teva and Medincell announce FDA acceptance of supplemental new drug application for Uzedy (risperidone) extended release injectable suspension as a treatment for patients with bipolar I disorder
25 February 2025 - Uzedy is currently approved in the US as a subcutaneous long-acting injectable for use every one or ...
Posted by Michael Wonder on 01 Mar 2025
Outlook Therapeutics resubmits biologics license application for ONS-5010 as a treatment for wet AMD to the US FDA
28 February 2025 - Outlook Therapeutics today announced it has re-submitted its biologics license application to the US FDA for ...
Posted by Michael Wonder on 01 Mar 2025
Valneva receives EMA’s positive CHMP opinion for adolescent label extension for chikungunya vaccine Ixchiq
28 February 2025 - If granted, Ixchiq will become the first vaccine against the chikungunya virus available in the EU ...
Posted by Michael Wonder on 01 Mar 2025
AbbVie receives positive CHMP opinion for upadacitinib (Rinvoq) for the treatment of adults with giant cell arteritis
28 February 2025 - The positive opinion is based on results from the pivotal Phase 3 SELECT-GCA trial that evaluated the ...
Posted by Michael Wonder on 01 Mar 2025
Lilly's Jaypirca (pirtobrutinib) recommended by CHMP for approval in the European Union for adults with relapsed or refractory chronic lymphocytic leukaemia previously treated with a BTK inhibitor
28 February 2025 - The positive opinion is based on results from the Phase 3 BRUIN CLL-321 trial, recently presented at ...
Posted by Michael Wonder on 01 Mar 2025
Enhertu recommended for approval in the EU by CHMP for patients with HER2 low or HER2 ultra-low metastatic breast cancer following at least one endocrine therapy
28 February 2025 - Recommendation based on DESTINY-Breast06 Phase 3 trial results which showed Enhertu demonstrated superiority versus chemotherapy with ...
Posted by Michael Wonder on 01 Mar 2025
Novartis oral Fabhalta (iptacopan) receives positive CHMP opinion for the treatment of adults living with C3 glomerulopathy
28 February 2025 - If approved, Fabhalta will be the only medicine indicated to selectively target the underlying cause of C3G, ...
Posted by Michael Wonder on 01 Mar 2025
Linvoseltamab recommended for EU approval by the CHMP to treat relapsed/refractory multiple myeloma
28 February 2025 - Regeneron Pharmaceuticals today announced that the EMA's CHMP has adopted a positive opinion recommending conditional marketing ...
Posted by Michael Wonder on 28 Feb 2025
FDA approves Odactra for the treatment of house dust mite allergy in young children
27 February 2025 - ALK today announced that the US FDA has approved ALK’s Odactra tablet for use in young children ...
Posted by Michael Wonder on 28 Feb 2025
ImmunityBio receives FDA RMAT designation for Anktiva and CAR-NK for the reversal of lymphopaenia in patients receiving standard of care chemotherapy/radiotherapy and in treatment of multiply relapsed locally advanced or metastatic pancreatic cancer
27 February 2025 - Regenerative medicine advanced therapy designation follows clinical data of absolute lymphocyte count and significant overall survival correlations ...
Posted by Michael Wonder on 28 Feb 2025
US FDA grants priority review to Sobi's supplemental biologics licence application for Gamifant (emapalumab-lzsg)
27 February 2025 - Sobi today announced that the US FDA has accepted the supplemental biologics license application for Gamifant (emapalumab-Izsg) ...
Posted by Michael Wonder on 27 Feb 2025
FDA accepts BLA for TLX250-CDx (Zircaix) for kidney cancer imaging, grants priority review
26 February 2025 - Telix today announces that the US FDA has accepted the biologics license application for its breakthrough investigational ...