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 25 Aug 2022
Iovance Biotherapeutics initiates biologics license application submission for lifileucel in advanced melanoma
25 August 2022 - First TIL therapy BLA submission initiated with U.S. FDA. ...
Posted by Michael Wonder on 25 Aug 2022
FDA plans to authorise bivalent boosters by Labor Day, sources say
24 August 2022 - The FDA plans to authorise updated versions of Pfizer-BioNTech’s and Moderna’s Covid boosters around Labor Day, ...
Posted by Michael Wonder on 25 Aug 2022
Ultomiris approved in Japan for the treatment of adults with generalised myasthenia gravis
25 August 2022 - First and only long-acting C5 complement inhibitor offers early onset and sustained efficacy, and has the ...
Posted by Michael Wonder on 25 Aug 2022
COVID-19 vaccine safety report (25 August 2022)
25 August 2022 - To 21 August 2022, the TGA has received 674 reports which have been assessed as likely to ...
Posted by Michael Wonder on 25 Aug 2022
Chugai obtains regulatory approval for Polivy for additional indication of previously untreated diffuse large B-cell lymphoma
24 August 2022 - The approval is based on the results from a Phase 3 POLARIX study in patients with ...
Posted by Michael Wonder on 25 Aug 2022
Tagrisso approved in Japan for the adjuvant treatment of patients with early-stage EGFR mutated lung cancer
25 August 2022 - Approval based on results from the ADAURA Phase 3 trial. ...
Posted by Michael Wonder on 25 Aug 2022
Janssen marks first approval worldwide for Tecvayli (teclistamab) with EC authorisation of first in class bispecific antibody for the treatment of patients with multiple myeloma
24 August 2022 - Teclistamab, an off the shelf subcutaneously administered therapy, induced deep and rapid responses in triple class ...
Posted by Michael Wonder on 25 Aug 2022
Lynparza approved in Japan as adjuvant treatment for patients with BRCA mutated HER2 negative high-risk early breast cancer
25 August 2022 - First and only approved medicine targeting BRCA mutations in early breast cancer ...
Posted by Michael Wonder on 25 Aug 2022
First gene therapy for adults with severe haemophilia A, BioMarin's Roctavian (valoctocogene roxaparvovec), approved by European Commission
24 August 2022 - Maintains orphan drug designation in the EU providing 10 years of market exclusivity. ...
Posted by Michael Wonder on 25 Aug 2022
AB Science announces that it has filed an application for conditional marketing authorisation to EMA for masitinib in the treatment of ALS
24 August 2022 - AB Science today announced that it has filed an application for conditional marketing authorisation to the EMA ...
Posted by Michael Wonder on 25 Aug 2022
Children with chronic graft versus host disease may now be prescribed Imbruvica (ibrutinib)
24 August 2022 - This is the first approved treatment option for children with cGVHD under 12 years of age and ...
Posted by Michael Wonder on 24 Aug 2022
Lifesaving cancer treatment out of reach for rural people
23 August 2022 - CAR T-cell therapy eradicates cancer in some patients but remains inaccessible to people who live far from ...
Posted by Michael Wonder on 24 Aug 2022
Prescription medicines: applications under evaluation
24 August 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...
Posted by Michael Wonder on 24 Aug 2022
Roche withdraws application for Tecentriq
25 August 2022 - Publication of AusPAR reveals the withdrawal of the application in July 2021. ...
Posted by Michael Wonder on 24 Aug 2022
FDA approves ibrutinib for paediatric patients with chronic graft versus host disease, including a new oral suspension
24 August 2022 - Today, the FDA approved ibrutinib (Imbruvica, Pharmacyclics) for paediatric patients ≥ 1 year of age with ...