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 27 Jan 2026
Health Canada authorises Gazyva (obinutuzumab) for adults with active lupus nephritis
26 January 2026 - Roche Canada is pleased to announce that on 22 January 2026, Health Canada has approved Gazyva ...
Posted by Michael Wonder on 27 Jan 2026
FDA accepts Leqembi Iqlik (lecanemab-irmb) supplemental biologics license application as a subcutaneous starting dose for the treatment of early Alzheimer’s disease under priority peview
26 January 2026 - Eisai and Biogen announced today that the US FDA has accepted for review Eisai’s supplemental biologics license ...
Posted by Michael Wonder on 27 Jan 2026
MannKind announces FDA approval of updated Afrezza label providing starting dose guidance when switching from multiple daily injections or insulin pump mealtime therapy
26 January 2026 - Updated initial conversion table based on clinical trials in adults showing significantly improved mealtime glycemic excursions. ...
Posted by Michael Wonder on 27 Jan 2026
Novo's Ozempic to gain insurance coverage for diabetes in Korea from February under new criteria
23 January 2026 - Starting in February, Korea's national health insurance will cover Novo Nordisk's Ozempic pre-filled pen, which contains ...
Posted by Michael Wonder on 26 Jan 2026
Cogent Biosciences announces breakthrough therapy designation for bezuclastinib in combination with sunitinib for patients with gastro-intestinal stromal tumours
26 January 2026 - Cogent will submit the PEAK new drug application under previously announced RTOR designation; on track to complete ...
Posted by Michael Wonder on 26 Jan 2026
GSK’s RSV vaccine, Arexvy, receives European approval for expanded use in all adults 18 years and older
26 January 2026 - GSK today announced that its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine, Arexvy, has been approved by ...
Posted by Michael Wonder on 26 Jan 2026
Thousands could benefit from new take-at-home treatment for advanced prostate cancer
23 January 2026 - NICE recommends life-extending daily pill which offers hope for people who cannot take standard treatment. ...
Posted by Michael Wonder on 26 Jan 2026
Patient organisations welcome approval of six life-extending cancer treatments through Ontario's FAST Program, urge national expansion
23 January 2026 - Leading patient organisations are welcoming Ontario's announcement that six cancer drugs are now being fast-tracked for ...
Posted by Michael Wonder on 26 Jan 2026
AstraZeneca's Tagrisso and Calquence among first oncology treatments granted accelerated access through Ontario's FAST Program
23 January 2026 - AstraZeneca Canada is pleased to announce that Tagrisso (osimertinib) and Calquence (acalabrutinib tablets) are now publicly funded ...
Posted by Michael Wonder on 23 Jan 2026
Minimal residual disease and complete response in multiple myeloma: use as outcomes to support accelerated approval
20 January 2026 - This guidance provides recommendations to sponsors about using minimal residual disease and complete response in multiple myeloma ...
Posted by Michael Wonder on 23 Jan 2026
Enhertu approved in China as the first and only HER2 directed ADC for the second-line treatment of patients with HER2 positive metastatic gastric cancer
22 January 2026 - Based on DESTINY-Gastric04 Phase 3 trial results that showed Enhertu demonstrated a statistically significant and clinically ...
Posted by Michael Wonder on 23 Jan 2026
What role does equity play in Australia’s health technology assessment processes? A review of the PBAC recommendations regarding vaccines
23 January 2026 - The Australian PBAC makes recommendations to the government on the listing of vaccines on the National Immunisation ...
Posted by Michael Wonder on 23 Jan 2026
Guardant Health receives FDA approval for Guardant360 CDx as companion diagnostic for Braftovi (encorafenib) combination in patients with BRAF V600E mutant metastatic colorectal cancer
22 January 2026 - Approval supported by data from Pfizer’s BREAKWATER trial demonstrating improved outcomes in BRAF V600E-mutant metastatic colorectal cancer ...
Posted by Michael Wonder on 22 Jan 2026
BioNTech receives FDA fast track designation for mRNA cancer immunotherapy candidate BNT113 in HPV16+ head and neck cancer
21 January 2026 - BioNTech today announced that the US FDA has granted fast track designation to BNT113, an investigational mRNA ...
Posted by Michael Wonder on 22 Jan 2026
Thousands living with lupus offered hope from twice yearly infusion
22 January 2026 - NICE approves breakthrough combination treatment that restores normal kidney function in almost half of patients with lupus ...