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 22 Oct 2025
Updated information about Pharmac’s priority lists (September 2025)
21 October 2025 - Pharmac’s Pūahoaho Report provides the latest information about applications for medicines, vaccines, and related products that we’ve ...
Posted by Michael Wonder on 22 Oct 2025
Sarilumab for the treatment of children/adolescents 2-17 years of age with polyarticular or oligoarticular juvenile idiopathic arthritis
22 October 2025 - NICE is unable to make a recommendation on the use of sarilumab (Kevzara) for the treatment of ...
Posted by Michael Wonder on 22 Oct 2025
Clascoterone for the treatment of patients 12 years of age and older with acne vulgaris
22 October 2025 - NICE is unable to make a recommendation on the use of clascoterone (Winlevi) for the treatment of patients ...
Posted by Michael Wonder on 22 Oct 2025
Tezspire approved in the EU for chronic rhinosinusitis with nasal polyps
22 October 2025 - Approval based on WAYPOINT Phase 3 results demonstrating reduced nasal polyp severity and nasal congestion, near ...
Posted by Michael Wonder on 22 Oct 2025
Lyvdelzi (seladelpar) receives Health Canada approval for the treatment of primary biliary cholangitis
21 October 2025 - Gilead Sciences today announced that Health Canada has approved Lyvdelzi (seladelpar) for the treatment of primary biliary ...
Posted by Michael Wonder on 22 Oct 2025
Sanofi’s Tzield accepted for expedited review in the US for stage 3 type 1 diabetes through FDA Commissioner's National Priority Voucher pilot program
20 October 2025 - The US FDA has accepted for expedited review the supplemental biologics license application for Tzield (teplizumab-mzwv) to ...
Posted by Michael Wonder on 22 Oct 2025
Pfizer Canada announces Health Canada approval of Abrysvo for adults 18+
21 October 2025 - With the approval of Arbysvo for adults aged 18+, there is now a way to help ...
Posted by Michael Wonder on 22 Oct 2025
GondolaBio receives US FDA orphan drug and fast track designations for PORT-77 for the treatment of erythropoietic protoporphyria and X-linked protoporphyria
21 October 2025 - PORT-77 is currently being investigated in the Phase 2A proof of concept trial, GATEWAY, with the primary ...
Posted by Michael Wonder on 22 Oct 2025
Immusoft receives FDA fast track designation for ISP-001, a first in class engineered B-cell therapy for MPS I
21 October 2025 - Prospectively designed for scalability and re-dosability, Immusoft's engineered B cells represent the next generation of advanced ...
Posted by Michael Wonder on 21 Oct 2025
Glaukos announces FDA approval of Epioxa
20 October 2025 - Epioxa expected to be commercially available in Q1, 2026. ...
Posted by Michael Wonder on 21 Oct 2025
Replimune announces FDA acceptance of BLA resubmission of RP1 for the treatment of advanced melanoma
20 October 2025 - Replimune today announced that the US FDA has accepted the resubmission of the biologics license application for ...
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 ...