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 14 Feb 2025
FDA approves first rapid-acting insulin biosimilar product for treatment of diabetes
14 February 2025 - Agency continues efforts to increase access to insulin treatment options. ...
Posted by Michael Wonder on 14 Feb 2025
FDA approves vimseltinib for symptomatic tenosynovial giant cell tumour
14 February 2025 - Today, the FDA approved vimseltinib (Romvimza, Deciphera Pharmaceuticals), a kinase inhibitor, for adult patients with symptomatic ...
Posted by Michael Wonder on 14 Feb 2025
European Commission approves CSL's Andembry (garadacimab) for the prevention of recurrent attacks of hereditary angioedema
13 February 2025 - Supported by the Phase 3 VANGUARD trial, this marks the third regulatory approval for Andembry, which was ...
Posted by Michael Wonder on 14 Feb 2025
LIB Therapeutics announces FDA acceptance of biologics license application for lerodalcibep to lower LDL-cholesterol across broad patient population
10 February 2025 - FDA has set a PDUFA target action date of 12 December 2025. ...
Posted by Michael Wonder on 14 Feb 2025
ViiV Healthcare and the pan-Canadian Pharmaceutical Alliance successfully finalise negotiations for Apretude for HIV-1 pre-exposure prophylaxis
13 February 2025 - ViiV Healthcare is pleased to announce it has successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance ...
Posted by Michael Wonder on 14 Feb 2025
Novartis receives Health Canada approval for Fabhalta oral treatment for adult patients with paroxysmal nocturnal haemoglobinuria
13 February 2025 - Fabhalta is the first oral monotherapy for previously treated and treatment naïve adults with paroxysmal nocturnal haemoglobinuria. ...
Posted by Michael Wonder on 13 Feb 2025
FDA grants fast track designation to PleoPharma's investigational new drug PP-01 for the mitigation of cannabis withdrawal symptoms in patients with cannabis use disorder: a potential first in class treatment
13 February 2025 - Phase 3 preparations underway. ...
Posted by Michael Wonder on 13 Feb 2025
Keytruda gets expanded coverage for 11 indications at cancer disease panel
13 February 2025 - After nearly two years of stalled discussions, the Keytruda (pembrolizumab) reimbursement expansion debate has finally begun. ...
Posted by Michael Wonder on 13 Feb 2025
Medical imaging agent gozetotide approved for diagnosis of prostate cancer
12 February 2025 - Gozetotide binds to the cancer cells with prostate-specific membrane antigen on their surface, making them visible during ...
Posted by Michael Wonder on 13 Feb 2025
FDA approves Roche’s Evrysdi tablet as first and only tablet for spinal muscular atrophy
12 February 2025 - New tablet formulation may provide greater freedom and independence for people with spinal muscular atrophy thanks ...
Posted by Michael Wonder on 13 Feb 2025
Olaparib for the treatment of patients with advanced, BRCA mutation positive, HER2 negative breast cancer after chemotherapy
12 February 2025 - NICE has published final evidence-based recommendations on the use of olaparib (Lynparza) for the treatment of ...
Posted by Michael Wonder on 13 Feb 2025
NICE joins international collaboration on HTA methods research
12 February 2025 - We’ve partnered with the US based ICER and the Canadian Drug Agency (CDA-AMC) to establish the Health ...
Posted by Michael Wonder on 13 Feb 2025
Selpercatinib for the treatment of patients with advanced thyroid cancer with a RET alteration untreated with a targeted cancer medicine
12 February 2025 - NICE has published final evidence-based recommendations on the use of selpercatinib (Retsevmo) for the treatment of ...
Posted by Michael Wonder on 13 Feb 2025
Selpercatinib for the treatment of patients with advanced thyroid cancer with a RET alteration after treatment with a targeted cancer medicine (final guidance)
12 February 2025 - NICE has published final evidence-based recommendations on the use of selpercatinib (Retsevmo) for the treatment of ...
Posted by Michael Wonder on 13 Feb 2025
US FDA approves expanded label for Astellas' Izervay (avacincaptad pegol intravitreal solution) for geographic atrophy
12 February 2025 - Izervay dosing approved beyond 12 months. ...