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 29 Jan 2025
EMA publishes agenda for 27-30 January 2025 CHMP meeting
27 January 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 29 Jan 2025
Alvotech and Teva announce filing acceptance of US biologics license applications for AVT05, a proposed biosimilar to Simponi and Simponi Aria (golimumab)
27 January 2025 - Alvotech and Teva Pharmaceuticals today announced that the US FDA has accepted for review biologics license applications ...
Posted by Michael Wonder on 29 Jan 2025
Von Hippel-Lindau disease drug Welireg listed on PBS slashing cost by $11,000 a month for patients
28 January 2025 - The treatment for Simon Goodrich’s disease has been costing $12,000 a month, but there has been a ...
Posted by Michael Wonder on 29 Jan 2025
FDA approves Ozempic (semaglutide) as the only GLP-1 RA to reduce the risk of worsening kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease
28 January 2025 - The approval is based on the results of the pivotal FLOW Phase 3b kidney outcomes trial and ...
Posted by Michael Wonder on 29 Jan 2025
Depemokimab accepted for review by the EMA for use in asthma with type 2 inflammation and CRSwNP
28 January 2025 - If approved, depemokimab will be the first ultra long-acting biologic with 6 month dosing. ...
Posted by Michael Wonder on 28 Jan 2025
Beckman Coulter receives FDA breakthrough device designation for Alzheimer's disease blood test
28 January 2025 - Beckman Coulter today announced the US FDA has granted breakthrough device designation to Beckman Coulter's Access p‑Tau217/β-Amyloid ...
Posted by Michael Wonder on 28 Jan 2025
Beacon Therapeutics granted FDA regenerative medicine advanced therapy designation for laru-zova (AGTC-501)
28 January 2025 - Recognises preliminary clinical evidence from the Phase 2 DAWN and SKYLINE trials of laru-zova in X-linked retinitis ...
Posted by Michael Wonder on 28 Jan 2025
Saol Therapeutics announces FDA acceptance of new drug application for SL1009 for treatment of pyruvate dehydrogenase complex deficiency
28 January 2025 - Saol Therapeutics announced today that the US FDA has accepted for review the new drug application for ...
Posted by Michael Wonder on 28 Jan 2025
Spesolimab for the treatment of patients with generalised pustular psoriasis flares
24 January 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 28 Jan 2025
Harnessing expertise to improve patient access to innovative health technologies
28 January 2025 - Introducing the Medicines and Medical Devices Access Initiative: a new collaboration that aims to improve patient access ...
Posted by Michael Wonder on 28 Jan 2025
January 2025 decisions
13 January 2025 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 28 Jan 2025
Vanda Pharmaceuticals accepts FDA opportunity for a hearing on new drug application for tradipitant in gastroparesis
27 January 2025 - Highlights faulty FDA review. ...
Posted by Michael Wonder on 28 Jan 2025
Tarlatamab for previously treated patients with advanced small-cell lung cancer
28 January 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 28 Jan 2025
Drugs for rare diseases – Ontario agreement
24 January 2025 - Today, the Governments of Canada and the province of Ontario signed the National Strategy for Drugs ...
Posted by Michael Wonder on 28 Jan 2025
Apellis receives approval of Syfovre (pegcetacoplan) in Australia for geographic atrophy
27 January 2025 - Apellis Pharmaceuticals announced today that the TGA has approved Syfovre (pegcetacoplan) for the every-other-month treatment of adult ...