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RSS FeedPosted by Michael Wonder on 31 Oct 2025
Public summary documents – July 2025 PBAC meeting
31 October 2025 - The Public Summary Documents (positive recommendations and subsequent decisions not to recommend) from the July 2025 PBAC ...
Posted by Michael Wonder on 31 Oct 2025
ICER publishes final evidence report on treatment for non-cystic fibrosis bronchiectasis
30 October 2025 - Independent appraisal committee voted unanimously on the positive net health benefit of brensocatib; but current pricing ...
Posted by Michael Wonder on 31 Oct 2025
Enhertu approved in Canada as the first and only HER2 directed therapy for patients with HR positive HER2 low or HER2 ultra low metastatic breast cancer, following disease progression after one or more endocrine therapies
29 October 2025 - Based on the DESTINY-Breast06 Phase 3 trial results demonstrating statistically significant and clinically meaningful progression-free survival ...
Posted by Michael Wonder on 31 Oct 2025
NICE’s backing of the prostate cancer drug abiraterone could help thousands and save the NHS millions
30 October 2025 - Today we’ve published final draft guidance recommending abiraterone and its generic variants in combination with androgen ...
Posted by Michael Wonder on 30 Oct 2025
FDA moves to accelerate biosimilar development and lower drug costs
29 October 2025 - The US FDA today announced significant action to make it faster and less costly to develop ...
Posted by Michael Wonder on 30 Oct 2025
FDA accepts BioMarin’s Palynziq (pegvaliase-pqpz) supplemental biologics license application for priority review to expand use to adolescents aged 12-17 with phenylketonuria
29 October 2025 - Application based on positive results from Phase 3 PEGASUS study, which demonstrated statistically significant blood phenylalanine lowering ...
Posted by Michael Wonder on 29 Oct 2025
ICER publishes evidence report on treatments for obesity
29 October 2025 - All three drugs result in substantial weight loss; the therapies are cost effective, but the very ...
Posted by Michael Wonder on 29 Oct 2025
Alphamab Oncology announces biparatopic HER2 targeting ADC JSKN003 was granted fast track designation by FDA for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
28 October 2025 - Alphamab Oncology announced that the biparatopic HER2-targeting antibody drug conjugate JSKN003 has been granted fast track designation ...
Posted by Michael Wonder on 28 Oct 2025
Cheaper medicine for kidney disease patients
28 October 20925 - Tens of thousands of Australians living with chronic kidney disease will soon have access to more ...
Posted by Michael Wonder on 28 Oct 2025
Koselugo approved in the EU for plexiform neurofibromas in adults with neurofibromatosis type 1
28 August 2025 - Approval based on KOMET Phase 3 trial results which showed 20% objective response rate in tumour ...
Posted by Michael Wonder on 28 Oct 2025
Cellectar Biosciences receives rare paediatric disease designation from US FDA for iopofosine I 131 in relapsed or refractory paediatric high-grade glioma
27 October 2025 - Cellectar Biosciences today announced the US FDA has granted rare paediatric drug designation for iopofosine I ...
Posted by Michael Wonder on 27 Oct 2025
US FDA approves updated indication for Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension (WHO Group 1 pulmonary hypertension) based on Phase 3 ZENITH study
27 October 2025 - Merck today announced that the US FDA has approved an update to the US product label based ...
Posted by Michael Wonder on 27 Oct 2025
Lilly's Omvoh (mirikizumab-mrkz) approved by US FDA as a single-injection maintenance regimen in adults with ulcerative colitis
27 October 2025 - Omvoh now offers patients a simplified maintenance experience with one monthly injection, replacing the previous two injection ...
Posted by Michael Wonder on 27 Oct 2025
Chronic kidney treatment made cheaper for people like Franki
28 October 2025 - A diabetes drug that helps to slow kidney damage will be made available to more people ...
Posted by Michael Wonder on 27 Oct 2025
Flaws in the FDA’s new priority voucher program
25 October 2025 - A new FDA program is being promoted as a tool to facilitate the development and approval of ...