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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 21 Oct 2025
FDA awards first ever national priority vouchers to nine sponsors
16 October 2025 - The US FDA today announced nine voucher recipients under the new Commissioner’s National Priority Voucher (CNPV) pilot ...
Posted by Michael Wonder on 20 Oct 2025
Fast track granted by FDA for NNZ-2591 in Phelan-McDermid syndrome
20 October 2025 - Neuren Pharmaceuticals today announced that the US FDA has granted fast track designation for NNZ-2591 for ...
Posted by Michael Wonder on 20 Oct 2025
ICER releases draft evidence report on treatment for smoking cessation
20 October 2025 - Public comment period now open until 17 November 2025; requests to make oral comment during public ...
Posted by Michael Wonder on 20 Oct 2025
Cogent Biosciences announces FDA breakthrough therapy designation for bezuclastinib
20 October 2025 - Detailed results from bezuclastinib’s positive SUMMIT trial evaluating bezuclastinib in patients with non-advanced systemic mastocytosis planned for ...
Posted by Michael Wonder on 20 Oct 2025
FDA approves Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
20 October 2025 - FDA approval based on superiority of Gazyva/Gazyvaro over standard therapy alone, as shown in Phase 2 NOBILITY ...
Posted by Michael Wonder on 20 Oct 2025
Ipsen’s Bylvay launches in Korea with national coverage for a rare childhood liver disease
20 October 2025 - Ipsen Korea has rolled out Bylvay (odevixibat) in Korea with national health insurance coverage, giving children ...
Posted by Michael Wonder on 20 Oct 2025
Xbrane provides regulatory update on FDA review of its ranibizumab biosimilar candidate
19 October 2025 - Xbrane Biopharma announce that the US FDA has issued a complete response letter to the Company’s biologics ...
Posted by Michael Wonder on 20 Oct 2025
PHARMAC proposes greater transparency for medicine funding decisions
20 October 2025 - PHARMAC is proposing changes to bring greater transparency and clarity to how medicine funding applications are ...
Posted by Michael Wonder on 19 Oct 2025
Artiva Biotherapeutics announces refractory rheumatoid arthritis as lead indication
16 October 2025 - Artiva Biotherapeutics announced today that the US FDA has granted fast track designation to AlloNK (also ...
Posted by Michael Wonder on 19 Oct 2025
Enterome receives FDA fast track designation in follicular lymphoma for lead OncoMimics immunotherapy EO2463
16 October 2025 - Enterome announces today that the US FDA has granted fast track designation for follicular lymphoma in the ...
Posted by Michael Wonder on 19 Oct 2025
Azurity Pharmaceuticals announces the FDA approval of Ferabright (ferumoxytol injection), the first and only iron-based contrast agent indicated for magnetic resonance imaging of the brain
17 October 2025 - Azurity Pharmaceuticals announced today that the US FDA has approved Ferabright (ferumoxytol injection), the first and only ...
Posted by Michael Wonder on 18 Oct 2025
FDA approves Novo Nordisk's oral semaglutide for cardiovascular risk reduction in adults with type 2 diabetes who are at high risk, including those who have not had a prior CV event
17 October 2025 - In the SOUL trial, oral semaglutide 14 mg reduced the risk of MACE by 14% compared to ...
Posted by Michael Wonder on 18 Oct 2025
CHMP recommends EU approval of Roche’s Gazyva/Gazyvaro for lupus nephritis
17 October 2025 - Positive recommendation based on Phase 2 NOBILITY and Phase 3 REGENCY data showing Gazyva/Gazyvaro’s superiority over standard ...
Posted by Michael Wonder on 18 Oct 2025
CHMP recommends EU approval of Brinsupri (brensocatib) for the treatment of non-cystic fibrosis bronchiectasis
17 October 2025 - Brinsupri was reviewed under CHMP's accelerated assessment pathway as it is considered of major interest for public ...
Posted by Michael Wonder on 18 Oct 2025
Sanofi’s Wayrilz recommended for EU approval by the CHMP to treat immune thrombocytopenia
17 October 2025 - Recommendation based on LUNA 3 Phase 3 study demonstrating rapid and durable platelet response and significant improvements ...