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 05 Jan 2024
ProfoundBio announces rinatabart sesutecan FDA fast track designation for patients with advanced ovarian cancer
5 January 2023 - ProfoundBio today announced that the US FDA has granted fast track designation for rinatabart sesutecan (Rina-S; ...
Posted by Michael Wonder on 05 Jan 2024
Accord BioPharma announces US FDA acceptance of biologics license application for proposed Stelara biosimilar DMB-3115
4 January 2024 - Biosimilar for Stelara (ustekinumab) seeks to treat several auto-immune disorders caused by overactive immune response. ...
Posted by Michael Wonder on 05 Jan 2024
CVS will remove AbbVie's Humira from some drug reimbursement lists in April
4 January 2024 - CVS Health said on Wednesday it will remove AbbVie’s blockbuster rheumatoid arthritis drug Humira from some ...
Posted by Michael Wonder on 04 Jan 2024
ICER to assess treatment for myelodysplastic syndrome
3 January 2024 - Report will be subject of CTAF meeting in July 2024; draft scoping document open to public ...
Posted by Michael Wonder on 04 Jan 2024
2023 FDA approvals
2 January 2024 - The FDA’s Center for Drug Evaluation and Research approved 55 new drugs in 2023, as the small ...
Posted by Michael Wonder on 04 Jan 2024
Updates to the HTA review research and analysis papers collection: draft HTA expert papers published
4 January 2024 - Two draft papers developed to support the deliberations of the HTA Review Reference Committee have been ...
Posted by Michael Wonder on 04 Jan 2024
Health Canada approves Pfizer Canada's gene therapy in haemophilia B
3 January 2024 - Pfizer Canada announced that Health Canada approved Beqvez (fidanacogene elaparvovec), an adeno-associated viral vector-based gene therapy for ...
Posted by Michael Wonder on 04 Jan 2024
Applied Therapeutics announces MAA validation and NDA submission of govorestat (AT-007) for treatment of classic galactosaemia
3 January 2024 - Submissions are based on positive results from Phase 3 registrational ACTION-Galactosemia Kids study demonstrating consistent long-term ...
Posted by Michael Wonder on 03 Jan 2024
MHRA’s new international recognition procedure goes live from 1 January 2024
2 January 2024 - In partnership with other global regulators, the international recognition procedure is expected to further help bring life-saving ...
Posted by Michael Wonder on 03 Jan 2024
Theratechnologies submits sBLA for Trogarzo intramuscular method of administration to FDA
2 January 2024 - Submission comes on the heels of the recent FDA approval of the Trogarzo intravenous push loading dose. ...
Posted by Michael Wonder on 03 Jan 2024
Drug makers set to raise US prices on at least 500 drugs in January
29 December 2023 - Drug makers including Pfizer, Sanofi and Takeda plan to raise prices in the United States on ...
Posted by Michael Wonder on 03 Jan 2024
More Americans can now get insulin for $35
2 January 2024 - More Americans with diabetes will get a break on their insulin costs in 2024. ...
Posted by Michael Wonder on 02 Jan 2024
European Medicines Agency validates Bristol Myers Squibb’s application for repotrectinib for the treatment of locally advanced or metastatic ROS1 positive non-small cell lung cancer and NTRK positive solid tumours
2 January 2024 - Application based on data from the registrational TRIDENT-1 and CARE trials showing robust responses and durable activity ...
Posted by Michael Wonder on 02 Jan 2024
Beyfortus approved in China for the prevention of RSV disease in infants
2 January 2024 - First and only RSV preventive option authorised for use in China ...
Posted by Michael Wonder on 02 Jan 2024
Expanded PBS listings make vital treatments more affordable
2 January 2024 - From 1 January 2024, Australians with advanced ovarian cancer, CLL, SLL, cystic fibrosis and atypical haemolytic uraemic ...