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 04 Mar 2026
Affinia Therapeutics granted FDA fast track designation for AFTX-201 as a treatment for people living with BAG3-associated dilated cardiomyopathy
4 March 2026 - Affinia Therapeutics today announced that the US FDA has granted fast track designation for AFTX-201, a potential ...
Posted by Michael Wonder on 04 Mar 2026
Problems in study implementation: It often affects patient reported outcomes.
2 March 2026 - Patient-reported outcomes are of great importance for the evaluation of new drugs. However, these outcomes are repeatedly ...
Posted by Michael Wonder on 04 Mar 2026
Boryung adds Xpovio to blood cancer portfolio under Antengene license deal
4 March 2026 - Boryung said Wednesday that it has signed a license in deal with Antengene, a Chinese pharmaceutical ...
Posted by Michael Wonder on 04 Mar 2026
J&J Korea receives reimbursement for Balversa in urothelial carcinoma
3 March 2026 - Johnson & Johnson Innovative Medicine Korea said it received reimbursement for Balversa (erdafitinib), a treatment for ...
Posted by Michael Wonder on 04 Mar 2026
SpliSense granted EMA EARLY PRIME designation for SPL84 in cystic fibrosis
3 March 2026 - SpliSense today announced that the EMA has granted early Priority Medicines (e-PRIME) designation to SPL84 for ...
Posted by Michael Wonder on 04 Mar 2026
FDA approves first generic of Flovent HFA for treatment of asthma
3 March 2026 - Today, the US FDA approved the first generic of Flovent HFA (fluticasone propionate) inhalation aerosol, 44 mcg/actuation, ...
Posted by Michael Wonder on 03 Mar 2026
Johnson & Johnson therapy nipocalimab granted US FDA fast track designation in systemic lupus erythematosus
3 March 2026 - Johnson & Johnson today announced that nipocalimaba was granted US FDA fast track designation as a potential ...
Posted by Michael Wonder on 03 Mar 2026
ICER publishes special report on treatment for ulcerative colitis and Crohn’s disease as part of CMS public comment process on Medicare drug price negotiations
3 March 2026 - The ICER today posted a special report on Entyvio (vedolizumab, Takeda) for the treatment of ulcerative ...
Posted by Michael Wonder on 03 Mar 2026
Xpovio receives reimbursement approval in South Korea for a second multiple myeloma indication
1 March 2026 - Antengene announced that South Korea's National Health Insurance Service has approved the reimbursement of Xpovio (selinexor) in ...
Posted by Michael Wonder on 03 Mar 2026
Alnylam receives positive recommendation from Canada's Drug Agency for the public reimbursement of Amvuttra (vutrisiran injection), the first and only RNAi therapeutic for the treatment of cardiomyopathy in adult patients with ATTR amyloidosis
2 March 2026 - Alnylam Canada is pleased to announce it has received a positive recommendation from Canada's Drug Agency for ...
Posted by Michael Wonder on 03 Mar 2026
Health Canada Approves Ozempic (semaglutide injection) to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes
2 March 2026 - Novo Nordisk announced today that Health Canada has approved Ozempic (semaglutide injection) to reduce the risk of ...
Posted by Michael Wonder on 03 Mar 2026
Expanded reimbursement for Roche Korea’s Evrysdi broadens access for SMA patients
3 March 2026 - Roche Korea said the expanded health insurance coverage and updated reimbursement criteria for the oral spinal ...
Posted by Michael Wonder on 02 Mar 2026
New Zealand Pharmaceutical Schedule - 1 March 2026
1 March 2026 - The March 2026 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 02 Mar 2026
Takeda and Protagonist announce US FDA accepts new drug application and grants priority review for rusfertide as a potential first in class therapy for polycythemia vera
2 March 2026 - Takeda and Protagonist Therapeutics today announced that the US FDA accepted the new drug application and granted ...
Posted by Michael Wonder on 02 Mar 2026
FDA accepts Viatris supplemental new drug application for MR-141 (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia
25 February 2026 - Viatris today announced that the US FDA has accepted for review the supplemental new drug application ...