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 17 Dec 2020
Amgen submits sotorasib new drug application to U.S. FDA for advanced or metastatic non-small cell lung cancer with KRAS G12C mutation
16 December 2020 - FDA granted breakthrough therapy designation for Sotorasib. ...
Posted by Michael Wonder on 17 Dec 2020
PBS Expenditure and Prescriptions Report 2019-20
17 December 2020 - The PBS Expenditure and Prescriptions Report 1 July 2019 to 30 June 2020 is now available. ...
Posted by Michael Wonder on 16 Dec 2020
Health Canada approves Zolgensma, the one-time gene therapy for paediatric patients with spinal muscular atrophy
16 December 2020 - Zolgensma is designed to address the genetic root cause of SMA by replacing the missing or defective ...
Posted by Michael Wonder on 16 Dec 2020
FDA authorises marketing of new implant to repair a torn anterior cruciate ligament
16 December 2020 - Today, the U.S. FDA granted marketing authorisation—under the De Novo premarket review pathway—for an anterior cruciate ligament ...
Posted by Michael Wonder on 16 Dec 2020
Durect Corporation announces DUR-928 granted FDA fast track designation for treatment of alcoholic hepatitis
16 December 2020 - Durect Corporation today announced that the U.S. FDA has granted fast track designation to DUR-928 for ...
Posted by Michael Wonder on 16 Dec 2020
In a petition, Boehringer warns FDA its definition of ‘strength’ threatens biosimilar competition
10 December 2020 - Arguing the FDA is precluding competition for biosimilar manufacturers, Boehringer Ingelheim has petitioned the agency to ...
Posted by Michael Wonder on 16 Dec 2020
NICE recommends Novartis’ wet AMD drug Beovu
16 December 2020 - The UK’s NICE has recommended Novartis’ anti-VEGF treatment Beovu (brolucizumab) for routine NHS use in wet ...
Posted by Michael Wonder on 16 Dec 2020
Gilead and Galapagos announce new commercialisation and development agreement for Jyseleca (filgotinib)
15 December 2020 - Gilead will not advance Jyseleca for the treatment of rheumatoid arthritis in the U.S. following FDA Type ...
Posted by Michael Wonder on 16 Dec 2020
Year in review
16 December 2020 - PHARMAC claims it funded 14 new medicines, including six new cancer medicines, and widened access to ...
Posted by Michael Wonder on 16 Dec 2020
Pressure mounts on EU drug regulator to approve Pfizer COVID-19 vaccine
15 December 2020 - Europe’s drug regulator is under increasing pressure to quickly approve the COVID-19 vaccine developed by U.S. giant ...
Posted by Michael Wonder on 16 Dec 2020
Fortress Biotech announces breakthrough therapy designation for CUTX-101, copper histidinate, for the treatment of Menkes disease
15 December 2020 - Rolling submission of new drug application to the FDA for CUTX-101 on track to begin in the ...
Posted by Michael Wonder on 16 Dec 2020
Health Canada approves Venclexta (venetoclax) in combination with azacitidine or low dose cytarabine for untreated acute myeloid leukaemia
15 December 2020 - Health Canada's approval of Venclexta for newly diagnosed AML patients who are ineligible for intensive chemotherapy is ...
Posted by Michael Wonder on 16 Dec 2020
Spark Biomedical receives FDA breakthrough device designation for infant transcutaneous auricular neurostimulation device, the Roo system
15 December 2020 - Breakthrough designation helps advance the therapy targeting a significant unmet need in the treatment of neonatal opioid ...
Posted by Michael Wonder on 16 Dec 2020
Exero Medical's smart sensor granted FDA breakthrough designation
15 December 2020 - Designation to expedite regulatory clearance process for Exero Medical's system, providing data on internal tissue healing in ...
Posted by Michael Wonder on 16 Dec 2020
US FDA approves world’s first rapid Covid test from Brisbane’s Ellume
16 March 2020 - The US FDA has approved the world’s first rapid at home COVID-19 test, developed by Brisbane-based ...