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 08 Oct 2021
Genentech’s anti-amyloid beta antibody gantenerumab granted FDA breakthrough therapy designation in Alzheimer’s disease
8 October 2021 - Gantenerumab is an investigational antibody in Phase 3 development for early Alzheimer's disease. ...
Posted by Michael Wonder on 08 Oct 2021
ChemoCentryx announces FDA approval of Tavneos (avacopan) in ANCA associated vasculitis
8 October 2021 - First FDA approved orally administered inhibitor of the complement 5a receptor. ...
Posted by Michael Wonder on 08 Oct 2021
Docs ‘use rubber stamp for drugs’
9 October 2021 - Pharmacists have raised the alarm over the influence of a US pharmaceutical corporation on Australian doctors ...
Posted by Michael Wonder on 08 Oct 2021
Booster shot for severely immunocompromised Australians
8 October 2021 - From next week Australians who are severely immunocompromised will be offered the option to receive a third ...
Posted by Michael Wonder on 08 Oct 2021
Recursion is granted FDA fast track designation for REC-2282 for the potential treatment of NF2 mutated meningiomas
7 October 2021 - Recursion today announced that the U.S. FDA has granted the company fast track designation for the ...
Posted by Michael Wonder on 08 Oct 2021
Health Canada approves the use of Rinvoq (upadacitinib) for the treatment of adults and adolescents with moderate to severe atopic dermatitis
7 October 2021 - Authorization is based on the results from three Phase 3 multicenter, randomized, double-blind, placebo-controlled registrational clinical trials ...
Posted by Michael Wonder on 08 Oct 2021
Arcutis submits topical roflumilast cream new drug application to FDA for the treatment of adults and adolescents with plaque psoriasis
4 October 2021 - Roflumilast cream demonstrated statistically significant superiority over vehicle on the primary endpoint of IGA Success and statistically ...
Posted by Michael Wonder on 08 Oct 2021
Surgery for women with birth injuries set to be subsidised again
7 October 2021 - Thousands of women who have been living with the pain of birth injuries have been given ...
Posted by Michael Wonder on 07 Oct 2021
BeiGene announces first regulatory approval in Australia for Brukinsa (zanubrutinib) for treatment of patients with Waldenström’s macroglobulinaemia
7 October 2021 - Represents Brukinsa’s second recent approval in the Asia-Pacific region, following October 1 approval in Singapore for treatment ...
Posted by Michael Wonder on 07 Oct 2021
The FDA should better regulate medical algorithms
7 October 2021 - Most do not require the agency’s approval, and those that do often don’t require clinical trials. ...
Posted by Michael Wonder on 07 Oct 2021
FDA still without a permanent leader as clock ticks down on acting head
7 October 2021 - The clock is ticking down on the time President Joe Biden has to appoint a permanent ...
Posted by Michael Wonder on 07 Oct 2021
Pfizer seeks US authorisation of Covid-19 vaccine for ages 5-11
8 October 2021 - The Pfizer vaccine could soon be available for children as young as five in the United States. ...
Posted by Michael Wonder on 07 Oct 2021
FDA issues final order and guidance on surgical staplers and staples for internal use
7 October 2021 - Today, the U.S. FDA announced several actions related to surgical stapler and staple regulation and safety. ...
Posted by Michael Wonder on 07 Oct 2021
ICER publishes evidence report on mavacamten for hypertrophic cardiomyopathy
7 October 2021 - Evidence is rated as promising but inconclusive to determine whether mavacamten provides a net health benefit for ...
Posted by Michael Wonder on 07 Oct 2021
FDA recognises Memorial Sloan-Kettering database of molecular tumour marker information
7 October 2021 - Today, the FDA granted recognition to a partial listing of the Memorial Sloan Kettering Cancer Center’s ...