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 Dec 2022
Zynlonta (loncastuximab tesirine) approved in the EU for the treatment of relapsed or refractory diffuse large B-cell lymphoma
21 December 2022 - Sobi and ADC Therapeutics today announced that the European Commission has granted conditional marketing authorisation for the ...
Posted by Michael Wonder on 21 Dec 2022
FDA approves Genentech’s Actemra for the treatment of COVID-19 in hospitalised adults
21 December 2022 - Actemra is the first FDA approved monoclonal antibody to treat COVID-19. ...
Posted by Michael Wonder on 21 Dec 2022
Sanofi Pasteur COVID-19 vaccine authorised by MHRA
21 December 2022 - VidPrevtyn Beta, the COVID-19 vaccine developed by Sanofi, has been authorised by the MHRA. ...
Posted by Michael Wonder on 21 Dec 2022
Pfizer announces FDA and EMA acceptance of etrasimod regulatory submissions for ulcerative colitis
21 December 2022 - Filings based on two Phase 3 trials demonstrating significant clinical remission versus placebo and safety profile ...
Posted by Michael Wonder on 21 Dec 2022
Classifying ageing as a disease could speed FDA drug approvals
21 December 2022 - The FDA considers ageing to be a natural process. This makes it difficult to get FDA approval ...
Posted by Michael Wonder on 21 Dec 2022
Idorsia submits a new drug application to the US FDA for aprocitentan for the treatment of patients with difficult to control hypertension
20 December 2022 - The application includes data from the Phase 3 registration trial of patients with resistant hypertension, where ...
Posted by Michael Wonder on 21 Dec 2022
European Commission approves Eladynos (abaloparatide) for the treatment of osteoporosis in post-menopausal women at increased risk of fracture
19 December 2022 - Radius Health announced that the European Commission has granted marketing authorisation for abaloparatide under the trade name ...
Posted by Michael Wonder on 21 Dec 2022
ICER publishes evidence report on treatments for multiple sclerosis
21 December 2022 - Evidence is rated as insufficient to differentiate the net health benefit between ublituximab and other monoclonal antibodies; ...
Posted by Michael Wonder on 21 Dec 2022
Radius Health’s Tymlos (abaloparatide) receives US FDA approval as a treatment to increase bone density in men with osteoporosis at high risk for fracture
20 December 2022 - Radius Health today announced that the US FDA has approved Tymlos (abaloparatide), a parathyroid hormone related peptide ...
Posted by Michael Wonder on 21 Dec 2022
CAR T cell therapy Breyanzi approved as relapsed or refractory large B-cell lymphoma second-line therapy in Japan
20 December 2022 - Bristol-Myers Squibb today announced that it has received approval in Japan for Breyanzi (lisocabtagene maraleucel), a ...
Posted by Michael Wonder on 21 Dec 2022
FDA grants fast track to Edesa Biotech's ARDS drug candidate
20 December 2022 - Edesa Biotech has received fast track designation from the US FDA for its monoclonal antibody candidate, EB05. ...
Posted by Michael Wonder on 21 Dec 2022
Lynparza in combination with abiraterone approved in the EU as first-line treatment for patients with metastatic castration-resistant prostate cancer
21 December 2022 - First approved PARP inhibitor to demonstrate clinically meaningful benefits in combination with a new hormonal agent. ...
Posted by Michael Wonder on 21 Dec 2022
PBS Expenditure and Prescriptions Report (2021-22)
21 December 2022 - The PBS Expenditure and Prescriptions Report 1 July 2021 to 30 June 2022 is now available. ...
Posted by Michael Wonder on 21 Dec 2022
Imfinzi plus chemotherapy approved in the EU as first immunotherapy regimen for patients with advanced biliary tract cancer
21 December 2022 - Approval based on TOPAZ-1 updated survival results showing Imfinzi combination reduced risk of death by 24% ...
Posted by Michael Wonder on 21 Dec 2022
Iveric Bio announces completion of rolling NDA submission to FDA for avacincaptad pegol for the treatment of geographic atrophy
20 December 2022 - Commercial launch preparations continue to accelerate. ...