Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 03 Nov 2025
US FDA approves Kygevvi (doxecitine and doxribtimine), the first and only treatment for adults and children living with thymidine kinase 2 deficiency
3 November 2025 - UCB today announced that Kygevvi has been granted approval by the US FDA for the treatment ...
Posted by Michael Wonder on 03 Nov 2025
Alvotech provides update on the status of US biologics license application for AVT05
2 November 2025 - Alvotech announced today that the US FDA has issued a complete response letter for Alvotech’s biologics ...
Posted by Michael Wonder on 02 Nov 2025
The slow-release dose
31 October 2023 - Canadians wait years for new drugs, even those already deemed safe, because public funding takes longer to ...
Posted by Michael Wonder on 02 Nov 2025
DoH publishes revised agenda for November 2025 PBAC meeting (version 6)
31 October 2025 - The DoH has published a revised agenda for the November 2025 PBAC meeting. ...
Posted by Michael Wonder on 01 Nov 2025
Johnson & Johnson submits application to US FDA for Stelara (ustekinumab) in the treatment of paediatric ulcerative colitis
31 October 2025 - Expanded Stelara indication seeks to treat children two years of age and older with moderately to severely ...
Posted by Michael Wonder on 01 Nov 2025
Elahere receives positive reimbursement recommendation by Canada's Drug Agency for certain types of platinum-resistant ovarian cancers
30 October 2025 - Elahere was submitted for reimbursement review 180 days prior to Health Canada's approval in line with ...
Posted by Michael Wonder on 31 Oct 2025
New Zealand Pharmaceutical Schedule - 1 November 2025
1 November 2025 - The November 2025 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 31 Oct 2025
Schedule of Pharmaceutical Benefits - 1 November 2025
1 November 2025 - The November 2025 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted 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
Enigma Biomedical USA announces FDA acceptance of new drug application for florquinitau F-18 (MK-6240), a tau PET Alzheimer’s disease radiodiagnostic
28 October 2025 - Enigma Biomedical today announced that the FDA has accepted a new drug application for MK-6240 (florquinitau F-18), ...