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 07 Mar 2023
Ionis announces FDA acceptance of new drug application for eplontersen for the treatment of hereditary transthyretin-mediated amyloid polyneuropathy
7 March 2023 - FDA assigns PDUFA action date of 22 December 2023. ...
Posted by Michael Wonder on 07 Mar 2023
BioMarin provides update on FDA review of Roctavian (valoctocogene roxaparvovec) gene therapy for adults with severe haemophilia A
7 March 2023 - FDA extends PDUFA target action date to 30 June 2023. ...
Posted by Michael Wonder on 07 Mar 2023
Dupixent (dupilumab) application for treatment of chronic spontaneous urticaria in adults and adolescents accepted for FDA review
7 March 2023 - The US FDA has accepted, for review, the supplemental biologics license application for Dupixent (dupilumab) to treat ...
Posted by Michael Wonder on 07 Mar 2023
PHARMAC funds two new treatments for lung cancer
7 March 2023 - PHARMAC has announced the funding of two new medicines - pembrolizumab (Keytruda) and atezolizumab (Tecentriq) for people ...
Posted by Michael Wonder on 07 Mar 2023
DoH makes further tweaks to the agenda for this week's PBAC meeting
7 March 2023 - We are now at version 4 with four revisions. ...
Posted by Michael Wonder on 07 Mar 2023
PHARMAC announces decision to fund Trikafta
7 March 2023 - Pharmac has today confirmed the funding of elexacaftor with tezacaftor and ivacaftor (Trikafta) for people with cystic ...
Posted by Michael Wonder on 06 Mar 2023
Ikena Oncology receives FDA fast track designation for novel AHR antagonist IK-175 in combination with nivolumab to treat urothelial carcinoma
6 March 2023 - Ikena Oncology today announced that the US FDA has granted fast track designation for IK-175, the ...
Posted by Michael Wonder on 06 Mar 2023
Will reimbursement criteria of SMA treatment Spinraza change?
6 March 2023 - The discussion will likely begin in earnest this month to expand reimbursement criteria for Spinraza (nusinersen ...
Posted by Michael Wonder on 06 Mar 2023
Ozempic-like weight loss drug Wegovy coming to the UK market, and it will cost a fraction of what Americans pay
3 March 2023 - Major drug store chains in the United Kingdom plan to start selling the weight loss drug Wegovy, ...
Posted by Michael Wonder on 06 Mar 2023
US FDA approves intramuscular administration for Merck’s MMRV family of vaccines: M-M-RII (measles, mumps and rubella virus vaccine live), Varivax (varicella virus vaccine live) and ProQuad (measles, mumps, rubella and varicella virus vaccine live)
6 March 2023 - With this additional route of administration, the MMRV family now joins other routinely recommended vaccines that ...
Posted by Michael Wonder on 06 Mar 2023
Roche receives FDA approval of label expansion for Ventana PD-L1 (SP263) assay to identify patients with locally advanced and metastatic non-small cell lung cancer eligible for Libtayo
6 March 2023 - The Ventana PD-L1 (SP263) assay helps determine which patients with non-small cell lung cancer may be eligible ...
Posted by Michael Wonder on 06 Mar 2023
Sooma Medical receives FDA breakthrough device designation for its innovative at home depression treatment device
6 March 2023 - Sooma Medical has been granted breakthrough device designation by the US FDA for its portable, patient-administered ...
Posted by Michael Wonder on 06 Mar 2023
Bristol Myers Squibb receives European Commission approval of Reblozyl (luspatercept) for anaemia in adult patients with non-transfusion-dependent beta thalassaemia
3 March 2023 - Third authorised indication in Europe for Reblozyl, a first in class treatment for patients with diseases ...
Posted by Michael Wonder on 06 Mar 2023
FDA accepts Eisai's filing of a supplemental biologics license application and grants priority review for traditional approval of Leqembi (lecanemab-irmb) for the treatment of Alzheimer's disease
5 March 2023 - Priority Review accelerates FDA review time with a PDUFA target action on 6 July 2023. ...
Posted by Michael Wonder on 05 Mar 2023
Our progress in the funding of medicines for rare disorders
3 March 2023 - PHARMAC will hear from people affected by rare disorders in its upcoming Rare Disorders Advisory Committee meeting ...