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 23 Feb 2023
FDA continues important work to advance medical products for patients with rare diseases
23 February 2023 - Patients with rare diseases are experts in their health condition. They provide a unique perspective, and ...
Posted by Michael Wonder on 23 Feb 2023
US Medicare says no change to Alzheimer's drug restrictions
23 February 2023 - The US Government health plan for people over the age of 65 on Wednesday said it ...
Posted by Michael Wonder on 23 Feb 2023
Aflibercept 8 mg BLA for treatment of wet age-related macular degeneration and diabetic macular oedema accepted for FDA priority review
23 February 2023 - BLA supported by two pivotal trials demonstrating non-inferior vision gains to Eylea (aflibercept) Injection, with vast majority ...
Posted by Michael Wonder on 23 Feb 2023
Octapharma USA requests FDA approval for wilate VWD prophylaxis supplement
23 February 2023 - Biologics license application supplement supported by study evaluating efficacy and safety of wilate prophylaxis in adults and ...
Posted by Michael Wonder on 23 Feb 2023
Moderna and Merck announce mRNA-4157/V940, an investigational personalised mRNA cancer vaccine, in combination with pembrolizumab, was granted breakthrough therapy designation by the FDA for adjuvant treatment of patients with high-risk melanoma following complete resection
22 February 2023 - Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial. ...
Posted by Michael Wonder on 23 Feb 2023
ONWARD receives new FDA breakthrough device designations for bladder control, alleviation of spasticity and blood pressure regulation after spinal cord injury
23 February 2023 - The company has now been awarded a total of eight FDA breakthrough device designations for its innovative ...
Posted by Michael Wonder on 23 Feb 2023
COVID-19 vaccine safety report (23 February 2023)
23 February 2023 - To 19 February 2023, over 44 million doses have been administered in Australia, as well as ...
Posted by Michael Wonder on 23 Feb 2023
Vir Biotechnology announces positive final draft guidance on sotrovimab from the UK’s NICE
22 February 2023 - Final draft guidance based on cost effectiveness evaluation of sotrovimab. ...
Posted by Michael Wonder on 23 Feb 2023
Daratumumab in combination with lenalidomide and dexamethasone for the first-line treatment of patients with multiple myeloma when stem cell transplantation is unsuitable
22 February 2023 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 22 Feb 2023
Pfizer’s elranatamab receives FDA and EMA filing acceptance
22 February 2023 - Submissions based on favourable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma. ...
Posted by Michael Wonder on 22 Feb 2023
Calquence tablet formulation approved in the EU for patients with chronic lymphocytic leukaemia
22 February 2023 - Approval based on ELEVATE-PLUS trials which showed bioequivalence and consistent dosing versus current capsule. ...
Posted by Michael Wonder on 22 Feb 2023
Imfinzi plus Imjudo approved in the EU for patients with advanced liver and non-small-cell lung cancers
22 February 2023 - Approvals based on significant survival benefits in HIMALAYA and POSEIDON Phase 3 trials. ...
Posted by Michael Wonder on 22 Feb 2023
Ataluren for the treatment of patients with Duchenne muscular dystrophy with a nonsense mutation in the dystrophin gene
22 February 2023 - This guidance updates and replaces NICE highly specialised technologies guidance HST3 on the use of ataluren for ...
Posted by Michael Wonder on 22 Feb 2023
Optinose submits supplemental new drug application for Xhance label expansion
21 February 2023 - Optinose today announced the submission of its supplemental new drug application to the US FDA to ...
Posted by Michael Wonder on 22 Feb 2023
MSAC publishes agenda for June 2023 ESC meeting
22 February 2023 - The MSAC Secretariat has published a list of applications scheduled to be considered by the ESC ...