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 Feb 2023
Ixazomib citrate and lenalidomide and dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma
22 February 2023 - This appraisal reviews the additional evidence collected as part of the Cancer Drugs Fund managed access agreement ...
Posted by Michael Wonder on 21 Feb 2023
'Amazing coincidence' Moderna offered free vaccines when asked to testify, Bernie Sanders says
19 February 2023 - But it was "a step in the right direction," the independent senator said. ...
Posted by Michael Wonder on 21 Feb 2023
Icosavax granted FDA fast track designation for IVX-A12
21 February 2023 - Icosavax today announced the US FDA has granted fast track designation for IVX-A12, a bivalent respiratory syncytial ...
Posted by Michael Wonder on 21 Feb 2023
US FDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review
21 February 2023 - US FDA has set an action date for August 2023. ...
Posted by Michael Wonder on 21 Feb 2023
Karyopharm and Menarini receive full marketing authorisation from the UK Medicines & Healthcare Products Regulatory Agency for Nexpovio (selinexor) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy
21 February 2023 - Based on results from Phase 3 BOSTON study, marketing authorisation expands multiple myeloma indication. ...
Posted by Michael Wonder on 21 Feb 2023
$130,000 a year for medicine is outrageous. But I blame the Government, not drug makers.
21 February 2023 - I don't blame President Biden for pursuing price controls. They are popular. Yet popularity does not ...
Posted by Michael Wonder on 21 Feb 2023
ICER publishes final evidence report on treatments for multiple sclerosis
21 February 2023 - Independent appraisal committee voted that evidence is not adequate to demonstrate a superior net health benefit ...
Posted by Michael Wonder on 21 Feb 2023
Alnylam announces US FDA acceptance of supplemental new drug application for Onpattro (patisiran) for the treatment of the cardiomyopathy of ATTR amyloidosis
21 February 2023 - PDUFA date set for 8 October 2023. ...
Posted by Michael Wonder on 21 Feb 2023
Pozelimab (C5 antibody) BLA for treatment of children and adults with ultra-rare CHAPLE disease accepted for FDA priority review
21 February 2023 - If approved, pozelimab would be the first and only treatment for those living with CHAPLE. ...
Posted by Michael Wonder on 21 Feb 2023
Biohaven's taldefgrobep alfa receives FDA fast track designation for spinal muscular atrophy
21 February 2023 - Taldefgrobep alfa, a myostatin-targeting biologic investigational agent, in Phase 3 development to increase muscle mass for ...
Posted by Michael Wonder on 21 Feb 2023
FDA accepts Orasis Pharmaceuticals' new drug application for CSF-1 for the treatment of presbyopia
21 February 2023 - Investigational, novel eye drop candidate was assigned PDUFA goal date of 22 October 2023. ...
Posted by Michael Wonder on 21 Feb 2023
NICE recommends 3 treatments for COVID-19 in final draft guidance
21 February 2023 - Everyone with COVID-19 at highest risk of developing severe disease will have access to clinically and ...
Posted by Michael Wonder on 21 Feb 2023
The FDA returns to its bad habits
20 February 2023 - The agency may nix a new treatment for a debilitating orphan disease. ...
Posted by Michael Wonder on 21 Feb 2023
First gene therapy for haemophilia B, CSL's Hemgenix, approved by the European Commission
20 February 2023 - Hemgenix underscores CSL's promise to deliver life-changing innovations that have the potential to help patients lead ...
Posted by Michael Wonder on 21 Feb 2023
Lutetium Lu 177 vipivotide tetraxetan for the treatment of adults with PSMA positive hormone-relapsed metastatic prostate cancer after two or more therapies
21 February 2023 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...