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 25 Dec 2025
Korea to expand Keytruda reimbursement to 11 new cancer uses starting 2026
24 December 2025 - Korea’s national health insurance program will broaden reimbursement for MSD’s blockbuster PD-1 inhibitor Keytruda in a ...
Posted by Michael Wonder on 25 Dec 2025
Health Canada approves Tevimbra (tislelizumab for injection) in combination with gemcitabine and cisplatin for the first-line treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma
23 December 2025 - Approval supported by results of the RATIONALE-309 study demonstrating statistically significant improvement in progression-free survival ...
Posted by Michael Wonder on 24 Dec 2025
FDA approves Omeros’ Yartemlea - first and only therapy indicated for transplant-associated thrombotic microangiopathy
24 December 2025 - Omeros Corporation today announced that the US FDA has approved Yartemlea (narsoplimab-wuug) for the treatment of haematopoietic ...
Posted by Michael Wonder on 24 Dec 2025
Organogenesis announces initiation of biologics license application for ReNu
23 December 2025 - Initial modules submitted to FDA under rolling review; final modules expected in the first half of ...
Posted by Michael Wonder on 24 Dec 2025
Millions need New Year medicines price cut
24 December 2025 - New data reveals Australians are still faced with the tough choice of skipping or rationing medicines—due ...
Posted by Michael Wonder on 24 Dec 2025
Pharma industry pushes back against generic drug price cuts
23 December 2025 - South Korea's pharmaceutical and biotech industry has begun mounting a coordinated backlash against the government's plan ...
Posted by Michael Wonder on 24 Dec 2025
Sanofi provides update on tolebrutinib regulatory submission in non-relapsing secondary progressive multiple sclerosis
24 December 2025 - The US FDA has issued a complete response letter for the new drug application of tolebrutinib ...
Posted by Michael Wonder on 24 Dec 2025
Thousands more people with advanced bowel cancer to benefit as NICE approves bevacizumab biosimilars
24 December 2025 - More than 7,000 people in England will now be able to access to a life-extending treatment for ...
Posted by Michael Wonder on 24 Dec 2025
Public Summary Documents – September 2025 PBAC meeting
24 December 2025 - The Public Summary Documents (positive recommendations) from the September 2025 PBAC meeting are now available. ...
Posted by Michael Wonder on 24 Dec 2025
Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia
23 December 2025 - Approval based on the LUNA 3 Phase 3 study that demonstrated rapid and durable platelet response and ...
Posted by Michael Wonder on 24 Dec 2025
Lilly’s Jaypirca wins Korea reimbursement for relapsed mantle cell lymphoma
10 October 2025 - Eli Lilly’s Jaypirca (pirtobrutinib) has been added to Korea’s national health insurance effective Oct. 1 for ...
Posted by Michael Wonder on 24 Dec 2025
Korea pharma groups warn price reform will cut 3.6 trillion won and cost jobs
22 December 2025 - Pharma associations form emergency committee to demand delay and joint review of planned generic price cuts. ...
Posted by Michael Wonder on 23 Dec 2025
Invivyd earns fast track designation for VYD2311, a vaccine alternative antibody to prevent COVID
23 December 2025 - Invivyd today announced that the US FDA has granted fast track designation for VYD2311, an investigational vaccine ...
Posted by Michael Wonder on 23 Dec 2025
Viridian Therapeutics announces BLA acceptance and priority review for veligrotug for the treatment of thyroid eye disease
22 December 2025 - PDUFA target action date of 30 June 2026. ...
Posted by Michael Wonder on 23 Dec 2025
FDA approves Novo Nordisk's Wegovy pill, the first and only oral GLP-1 for weight loss in adults
22 December 2025 - 1.5 mg starting dose available in early January for $149/month with savings offers; Wegovy pill is being ...