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 13 Aug 2021
PBS arrangements for tocilizumab shortage
13 August 2021 - The sponsor of tocilizumab (Actemra) Roche has notified the TGA of shortages of multiple presentations of tocilizumab ...
Posted by Michael Wonder on 12 Aug 2021
Australian Technical Advisory Group on Immunisation weekly COVID-19 meeting - 11 August 2021 update
12 August 2021 - ATAGI met on Wednesday 11 August 2021 to review the latest developments relating to adverse events observed ...
Posted by Michael Wonder on 12 Aug 2021
Biden urges Congress to lower prescription drug costs
13 August 2021 - President Joe Biden on Thursday called on U.S. law makers to enact legislation aimed at lowering ...
Posted by Michael Wonder on 12 Aug 2021
Second U.S. FDA breakthrough device designation granted to CytoSorbents' DrugSorb-ATR anti-thrombotic removal system adding the removal of market leading direct oral anti-coagulants during urgent cardiothoracic surgery
12 August 2021 - FDA breakthrough designation granted to CytoSorbents' DrugSorb-ATR for removal of apixaban and rivaroxaban to reduce the risk ...
Posted by Michael Wonder on 12 Aug 2021
FDA grants first of its kind indication for chronic sleep disorder treatment
12 August 2021 - The U.S. Food and Drug Administration today approved a new indication for Xywav for idiopathic hypersomnia in ...
Posted by Michael Wonder on 12 Aug 2021
Thousands of south Aucklanders could benefit from Medsafe approving new diabetes drug
12 August 2021 - Medsafe’s approval of a new drug for type 2 diabetes could dramatically change the lives of ...
Posted by Michael Wonder on 12 Aug 2021
Ellis Unger, an outspoken FDA veteran, retires
12 August 2021 - A top FDA official known for speaking out against controversial drug approval decisions, Ellis Unger, retired ...
Posted by Michael Wonder on 12 Aug 2021
VTX-801 receives U.S. FDA fast track designation for the treatment of Wilson disease
12 August 2021 - Vivet Therapeutics and Pfizer today announced the U.S. FDA has granted fast track designation to VTX-801, ...
Posted by Michael Wonder on 12 Aug 2021
Junshi Biosciences and Coherus announce U.S. FDA breakthrough therapy designation granted for toripalimab for first-line treatment of nasopharyngeal carcinoma
12 August 2021 - First-line nasopharyngeal indication and second/third line indications to be concurrently submitted 3Q 2021 in the toripalimab ...
Posted by Michael Wonder on 12 Aug 2021
Jazz Pharmaceuticals announces U.S. FDA approval of Xywav (calcium, magnesium, potassium and sodium oxybates) oral solution for idiopathic hypersomnia in adults
12 August 2021 - Xywav is the first and only FDA approved treatment for idiopathic hypersomnia. ...
Posted by Michael Wonder on 12 Aug 2021
Drug shortages putting patients at risk
12 August 2021 - Pharmacists are reporting critical shortages in heart and stroke medications, mental health drugs and HRT therapies ...
Posted by Michael Wonder on 12 Aug 2021
MHRA nod for Janssen’s relapsing multiple sclerosis drug Ponvory
12 August 2021 - The UK’s Medicines and Healthcare Products Regulatory Agency has approved Ponvory (ponesimod) for the treatment relapsing ...
Posted by Michael Wonder on 12 Aug 2021
FDA to authorise third vaccine dose for people with weak immune systems
11 August 2021 - The decision to expand the emergency use of both the Pfizer-BioNTech and Moderna vaccines is meant to ...
Posted by Michael Wonder on 12 Aug 2021
NICE draft guidance recommends abemaciclib for advanced breast cancer
12 August 2021 - NICE has today published draft guidance which recommends a twice daily pill abemaciclib (Verzenios; Eli Lilly) as ...
Posted by Michael Wonder on 12 Aug 2021
Reclassification of software based medical devices
12 August 2021 - Recent changes to regulation of software based medical devices came into effect in early 2021, which ...