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 Jan 2024
Health Canada approves Otsuka and Lundbeck's Rexulti (brexpiprazole) for the symptomatic management of agitation associated with Alzheimer's dementia
24 January 2024 - Otsuka Pharmaceutical Canada and Lundbeck Canada announce that Health Canada has issued a Notice of Compliance ...
Posted by Michael Wonder on 25 Jan 2024
Hospital prices for physician administered drugs for patients with private insurance
25 January 2024 - In this study, we used 2020–2021 national Blue Cross Blue Shield claims data regarding patients in the ...
Posted by Michael Wonder on 24 Jan 2024
FDA's ISTAND Pilot Program accepts submission of first artificial intelligence based and digital health technology for neuroscience
23 January 2024 - FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research recently accepted a ...
Posted by Michael Wonder on 24 Jan 2024
US FDA seeks 'boxed warning' for CAR-T cancer therapies
22 January 2024 - The US health regulator on Monday asked a host of drug makers, including Gilead Sciences, Johnson ...
Posted by Michael Wonder on 24 Jan 2024
UroGen initiates submission of a rolling NDA to the FDA for UGN-102
24 January 2024 - UroGen Pharma today announced the submission of the Chemistry, Manufacturing, and Controls section of the new drug ...
Posted by Michael Wonder on 24 Jan 2024
Heron Therapeutics announces FDA approval of Zynrelef indication expansion to include additional orthopaedic and soft tissue procedures
23 January 2024 - Expanded indication for Zynrelef now covers approximately 13 million procedures annually. ...
Posted by Michael Wonder on 24 Jan 2024
Jardiance (empagliflozin) receives authorisation from Health Canada for the treatment of adults with chronic kidney disease
23 January 2024 - Health Canada has authorised Jardiance (empagliflozin) to reduce the risk of sustained eGFR decline, end stage kidney ...
Posted by Michael Wonder on 23 Jan 2024
TGA approves RSV vaccine for use through private prescription for Australians over 60
17 January 2024 - A vaccine for respiratory syncytial virus has been approved by the TGA and will be available through ...
Posted by Michael Wonder on 23 Jan 2024
Lower drug costs are just a federal license away. But they require Biden Administration leadership.
23 January 2024 - It’s a longstanding Government failure to never use federal “march-in” licensing rights to lower drug prices. It’s ...
Posted by Michael Wonder on 23 Jan 2024
Theratechnologies receives update from FDA on tesamorelin F8 supplemental biologics license application
23 January 2024 - FDA continues to review the file past the Prescription Drug User Fee Act goal date of ...
Posted by Michael Wonder on 23 Jan 2024
4DMT receives rare paediatric disease designation from FDA for aerosolised 4D-710 for treatment of cystic fibrosis lung disease
23 January 2024 - Interim data update from Phase 1/2 AEROW clinical trial expected in mid-2024, and pivotal trial planning ...
Posted by Michael Wonder on 23 Jan 2024
Ensysce Biosciences announces FDA breakthrough therapy designation granted for PF614-MPAR
23 January 2024 - FDA acknowledges significant potential impact of MPAR's oral overdose protection. ...
Posted by Michael Wonder on 23 Jan 2024
Autolus Therapeutics announces acceptance of biologics license application for obecabtagene autoleucel as a potential treatment for relapsed/refractory adult B-cell acute lymphoblastic leukaemia
22 January 2024 - PDUFA goal date is 16 November 2024. ...
Posted by Michael Wonder on 23 Jan 2024
PHARMAC - 2023 in review (Part 2)
23 January 2024 - This week, we have reviewed the listing of innovative (patent protected) health care technologies in the ...
Posted by Michael Wonder on 23 Jan 2024
Remdesivir and the combination of tixagevimab and cilgavimab for the treatment of patients with COVID-19 disease
18 January 2024 - NICE has published additional draft guidance on the use of remdesivir and the combination of tixagevimab ...