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RSS FeedPosted by Michael Wonder on 13 Aug 2021
Congress should fix FDA’s accelerated approval program for the next 30 years
12 August 2021 - The FDA's approval of the Alzheimer’s drug Aduhelm has sparked a broader debate on the merits ...
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
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
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
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
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 ...
Posted by Michael Wonder on 12 Aug 2021
COVID-19 vaccine weekly safety report (12 August 2021)
12 August 2021 - To 8 August 2021, approximately 13.7 million vaccine doses have been given in Australia – 9.1 million ...
Posted by Michael Wonder on 12 Aug 2021
FDA approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) combination for first-line treatment of adult patients with advanced renal cell carcinoma
11 August 2021 - Keytruda plus Lenvima is now approved for two types of cancer, including advanced renal cell carcinoma. ...
Posted by Michael Wonder on 11 Aug 2021
‘We don’t unlearn’: what the pandemic has taught regulators about real world data
11 August 2021 - During the pandemic, regulatory agencies deployed emergency measures left and right to speed care to patients. ...
Posted by Michael Wonder on 11 Aug 2021
Groups make own drugs to fight high drug prices, shortages
11 August 2021 - Impatient with years of inaction in Washington on prescription drug prices, U.S. hospital groups, start-ups and ...
Posted by Michael Wonder on 11 Aug 2021
New Alzheimer's drug aducanumab is dividing doctors and patients, as the TGA weighs up its risk-benefit profile
12 August 2021 - After a decades-long career as a biology teacher, John Rodgers applies the strict logic of a ...