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 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 ...
Posted by Michael Wonder on 22 Dec 2025
FDA approves Roche’s Lunsumio Velo for subcutaneous use in relapsed or refractory follicular lymphoma
22 December 2025 - Approval supported by data demonstrating compelling complete response rate in third-line or later follicular lymphoma, which ...
Posted by Michael Wonder on 22 Dec 2025
Enhertu granted breakthrough therapy designation in the US as post-neo-adjuvant therapy for patients with HER2 positive early breast cancer
22 December 2025 - Tenth breakthrough therapy designation for Daiichi Sankyo and AstraZeneca’s Enhertu with the latest based on DESTINY-Breast05 ...
Posted by Michael Wonder on 20 Dec 2025
Alphamab Oncology announces biparatopic HER2 targeting ADC JSKN003 was granted breakthrough therapy designation by the FDA for the treatment of PROC
20 December 2025 - Alphamab Oncology announced that the biparatopic HER2 targeting antibody drug conjugate JSKN003, independently by the US FDA ...
Posted by Michael Wonder on 20 Dec 2025
Beren, through its subsidiary Mandos, submits new drug application to US FDA for adrabetadex in infantile-pnset NPC
19 December 2025 - Beren Therapeutics today announced that its subsidiary Mandos has submitted a new drug application to the US ...
Posted by Michael Wonder on 20 Dec 2025
Spero announces NDA resubmission of tebipenem hydrobromide by GSK to the FDA for the treatment of complicated urinary tract infections, including pyelonephritis
19 December 2025 - Spero Therapeutics today announced that its development partner, GSK, filed a new drug application resubmission to ...