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 28 Jul 2022
To promote innovation, Congress and companies should support drug development cost disclosure
28 July 2022 - Congress should pass the proposed Pharmaceutical Research Transparency Act of 2022 to mandate drug companies provide ...
Posted by Michael Wonder on 28 Jul 2022
Novartis’ Beovu recommended by NICE
28 July 2022 - Patients set to benefit from new treatment for sight-threatening eye condition ...
Posted by Michael Wonder on 28 Jul 2022
Acer Therapeutics and Relief Therapeutics announce FDA acceptance for review of NDA resubmission for ACER-001 for treatment of UCDs
28 July 2022 - Prescription Drug User Fee Act target action date set for 15 January 2023. ...
Posted by Michael Wonder on 28 Jul 2022
COVID-19 vaccine safety report (28 July 2022)
29 July 2022 - To 24 July 2022, the TGA has received 615 reports which have been assessed as likely to ...
Posted by Michael Wonder on 28 Jul 2022
Big data use for public health: publication of Big Data Steering Group workplan 2022-25
28 July 2022 - The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies has ...
Posted by Michael Wonder on 28 Jul 2022
EMA reviewing data on sabizabulin for COVID-19
27 July 2022 - The EMA’s Emergency Task Force has started a review of data on the use of sabizabulin ...
Posted by Michael Wonder on 28 Jul 2022
Cidara Therapeutics submits NDA for rezafungin and announces license agreement with Melinta Therapeutics for commercialisation of rezafungin in the U.S.
27 July 2022 - Submitted new drug application for rezafungin for candidemia and invasive candidiasis to the U.S. FDA on 22 ...
Posted by Michael Wonder on 27 Jul 2022
FDA grants import discretion of Bracco's iodinated contrast medium Iomeron (iomeprol) to address supply shortages
27 July 2022 - Bracco Diagnostics today announced that the U.S. FDA granted import discretion of Iomeron (iomeprol) into the ...
Posted by Michael Wonder on 27 Jul 2022
GSK announces US FDA approval of Benlysta (belimumab) for paediatric patients with active lupus nephritis
27 July 2022 - Benlysta is now the first and only biologic approved for adults and children who have lupus ...
Posted by Michael Wonder on 27 Jul 2022
AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) in Crohn's disease
27 July 2022 - Submissions are supported by three Phase 3 clinical trials demonstrating upadacitinib achieved the co-primary endpoints of clinical ...
Posted by Michael Wonder on 27 Jul 2022
Lexicon announces FDA acceptance of new drug application for sotagliflozin to treat heart failure
27 July 2022 - NDA supported by SOLOIST-WHF and SCORED Global Phase 3 Program evaluating sotagliflozin in almost 12,000 people. ...
Posted by Michael Wonder on 27 Jul 2022
MS Health push for nurses to hand out abortion pills
27 July 2022 - Nurses and midwives would prescribe medical abortion pills under a push by the company that imports ...
Posted by Michael Wonder on 27 Jul 2022
MSAC publishes agenda for November 2022 meeting
27 July 2022 - 12 agenda items for consideration at the 24-25 November 2022 meeting. ...
Posted by Michael Wonder on 27 Jul 2022
FDA explains the ins and outs of real-time oncology review program in new guidance
26 July 2022 - Cancer drugs under development that show substantial promise over existing therapies and have simple study designs, as ...
Posted by Michael Wonder on 27 Jul 2022
Agenda for the November 2022 PBAC meeting
27 July 2022 - The agenda for the November 2022 PBAC meeting is now available. ...