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RSS FeedPosted by Michael Wonder on 08 Sep 2025
SMC - September 2025 decisions
8 September 2025 - The SMC has today published advice on two medicines. ...
Posted by Michael Wonder on 06 Sep 2025
FDA announces real-time release of complete response letters, posts previously unpublished batch of 89
4 September 2025 - The US FDA today announced that it will release future complete response letters promptly after they are ...
Posted by Michael Wonder on 06 Sep 2025
Sol-Gel announces Health Canada approval of Epsolay
4 September 2025 - - Sol-Gel Technologies announced today that on 27 August 2 2025 Health Canada issued a Notice ...
Posted by Michael Wonder on 06 Sep 2025
Accrufer assigned priority review in the US by FDA in children with iron deficiency anaemia
4 September 2025 - Pending successful review, approval in the US is anticipated in 2026. ...
Posted by Michael Wonder on 05 Sep 2025
DoH publishes agenda for November 2025 PBAC meeting (version 3)
5 September 2025 - The DoH has published a revised agenda for the November 2025 PBAC meeting. ...
Posted by Michael Wonder on 05 Sep 2025
US FDA approves Henlius and Organon’s Bildyos (denosumab-nxxp) and Bilprevda (denosumab-nxxp), biosimilars to Prolia (denosumab) and Xgeva (denosumab), respectively
2 September 2025 - Shanghai Henlius Biotech and Organon today announced the US FDA has approved Bildyos (denosumab-nxxp) injection 60 mg/mL ...
Posted by Michael Wonder on 05 Sep 2025
Ulcerative colitis: comparative study provides important insights
2 September 2025 - The data show no additional benefit of guselkumab compared to golimumab. ...
Posted by Michael Wonder on 05 Sep 2025
Agios provides update on US PDUFA goal date for Pyrukynd (mitapivat) in thalassemia
4 September 2025 - Agios Pharmaceuticals today announced that the US FDA has extended the PDUFA goal date for the supplemental ...
Posted by Michael Wonder on 04 Sep 2025
Lilly's olomorasib receives US FDA's breakthrough therapy designation for the treatment of certain newly diagnosed metastatic KRAS G12C-mutant lung cancers
4 September 2025 - The breakthrough therapy designation for olomorasib is based on data from the Phase 1/2 LOXO-RAS-20001 trial and ...
Posted by Michael Wonder on 04 Sep 2025
FDA grants Hernexeos breakthrough therapy designation for first-line use in HER2 mutant advanced NSCLC
3 September 2025 - Breakthrough therapy designation is based on results from the Beamion-LUNG 1 clinical trial evaluating Hernexeos (zongertinib tablets) ...
Posted by Michael Wonder on 04 Sep 2025
Achieve Life Sciences announces FDA acceptance of cytisinicline new drug application for treatment of nicotine dependence for smoking cessation
3 September 2025 - Achieve Life Sciences today announced that the US FDA has accepted the cytisinicline new drug application for ...
Posted by Michael Wonder on 03 Sep 2025
Menarini Group's obicetrapib and obicetrapib/ezetimibe marketing authorisation applications accepted for review by the EMA for the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia
2 September 2025 - Menarini today announced that EMA has validated the marketing authorisation application for obicetrapib, a selective cholesteryl ...
Posted by Michael Wonder on 03 Sep 2025
FDA accepts Shionogi’s ensitrelvir NDA as the first oral therapy for the prevention of COVID-19 following exposure
2 September 2025 - Shionogi announced the US FDA has accepted a new drug application for ensitrelvir fumaric acid, an investigational ...
Posted by Michael Wonder on 03 Sep 2025
Rolling sBLA initiated to the US FDA for Leqembi Iqlik (lecanemab-irmb) as a subcutaneous starting dose for the treatment of early Alzheimer's disease under fast track status
3 September 2025 - BioArctic partner Eisai announced today that they have initiated a rolling submission of the supplemental biologics license ...
Posted by Michael Wonder on 03 Sep 2025
ICER publishes final evidence report on treatments for spinal muscular atrophy
2 September 2025 - Independent appraisal committee votes reflect uncertainty in net health benefit for apitegromab and for add-on treatments ...