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 04 Jan 2023
Enhertu type II variation application validated by EMA for the treatment of HER2 mutant metastatic non-small-cell lung cancer
4 January 2022 - Submission based on DESTINY-Lung02 and DESTINY-Lung01 Phase 2 trial results which showed Daiichi Sankyo and AstraZeneca’s Enhertu ...
Posted by Michael Wonder on 04 Jan 2023
Updated agenda for the March 2023 PBAC meeting
4 January 2023 - The agenda for the March 2023 PBAC meeting has been updated. ...
Posted by Michael Wonder on 04 Jan 2023
Orasis Pharmaceuticals submits new drug application for investigational novel eye drop candidate, CSF-1, for the treatment of presbyopia
3 January 2023 - Phase 3 NEAR-1 and NEAR-2 clinical trials, involving over 600 patients, met primary and key secondary ...
Posted by Michael Wonder on 04 Jan 2023
Janssen submits marketing authorisation application to the European Medicines Agency seeking approval of talquetamab for the treatment of patients with relapsed or refractory multiple myeloma
3 January 2023 - Janssen today announced the submission of a marketing authorisation application to the EMA seeking approval of ...
Posted by Michael Wonder on 04 Jan 2023
European Medicines Agency validates marketing authorisation application for Trodelvy (sacituzumab govitecan-hziy) for pre-treated HR+/HER2- metastatic breast cancer
3 January 2023 - Application based on statistically significant and clinically meaningful overall survival and progression-free survival results from the Phase ...
Posted by Michael Wonder on 04 Jan 2023
European Medicines Agency validates application for extension of indication for Vozogo (vosoritide) for injection to treat children with achondroplasia under the age of 2
4 January 2023 - BioMarin submits supplemental new drug application to US FDA to expand label to treat children with achondroplasia ...
Posted by Michael Wonder on 04 Jan 2023
Samsung Bioepis announces Health Canada approval of citrate free high concentration of Humira biosimilar (adalimumab; SB5)
3 January 2023 - With the approval, Samsung Bioepis has both low (40 mg/0.8 mL) and high (40 mg/0.4 mL) concentration ...
Posted by Michael Wonder on 04 Jan 2023
Burning Rock received FDA breakthrough device designation for its OverC multi-cancer detection blood test
3 January 2023 - Burning Rock today announced that its OverC Multi-Cancer Detection Blood Test (MCDBT) has been granted breakthrough device ...
Posted by Michael Wonder on 03 Jan 2023
Pertuzumab and pertuzumab with trastuzumab in breast cancer: now a minor additional clinical benefit
2 January 2023 - Advantages in overall survival and in relapses often only become apparent after a long period of ...
Posted by Michael Wonder on 03 Jan 2023
US FDA grants breakthrough designation for blood test to help diagnose inaccessible brain tumours
2 January 2023 - Datar Cancer Genetics now has three breakthrough designations granted by the US FDA, including liquid biopsies ...
Posted by Michael Wonder on 03 Jan 2023
Hansa Biopharma announces positive reimbursement decision for Idefirix (imlifidase) in the Czech Republic
2 January 2023 - Idefirix is the first and only product approved for use in highly sensitised patients waiting for a ...
Posted by Michael Wonder on 03 Jan 2023
Legend Biotech announces acceptance of its new drug application for ciltacabtagene autoleucel in China
2 January 2023 - Legend Biotech announced today that China’s NMPA has formally accepted its new drug application for ciltacabtagene ...
Posted by Michael Wonder on 03 Jan 2023
Yescarta now approved in Japan for initial treatment of relapsed/refractory large B-cell lymphoma
23 December 2022 - Based on landmark ZUMA-7 study, patients with LBCL treated with Yescarta in second-line achieved four-fold greater improvement ...
Posted by Michael Wonder on 03 Jan 2023
Libtayo (cemiplimab) approved in Japan for advanced or recurrent cervical cancer
23 December 2022 - Regeneron Pharmaceuticals today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted ...
Posted by Michael Wonder on 03 Jan 2023
Changes to the PBS to make medicines more affordable
3 January 2023 - From 1 January 2023, the maximum cost of general prescriptions under the PBS will fall for the ...