Blog
RSS FeedPosted by Michael Wonder on 05 Mar 2024
Zevra Therapeutics provides FDA update on the PDUFA action date for arimoclomol as a treatment for Niemann-Pick disease type C
4 March 2024 - The new PDUFA action date set by the FDA is 21 September 2024. ...
Posted by Michael Wonder on 28 Feb 2024
Minister announces parallel assessment means new medicines assessed sooner
28 February 2024 - PHARMAC is changing its process so it can assess a funding application at the same time Medsafe ...
Posted by Michael Wonder on 14 Feb 2024
Rocket Pharmaceuticals announces update on FDA review timeline of Kresladi (marnetegragene autotemcel) for the treatment of severe leukocyte adhesion deficiency-I
13 February 2024 - New Prescription Drug User Fee Act date of 30 June 2024. ...
Posted by Michael Wonder on 26 Jan 2024
Liquidia provides update on new drug application for Yutrepia (treprostinil) inhalation powder
25 January 2024 - Liquidia announced today that the US FDA provided an update on its review of the new drug ...
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 09 Dec 2023
Medicines lobby says the PBS has not kept up with advances — or approvals — in medicines
8 December 2023 - Little Jack Roche was five weeks old when diagnosed with cystic fibrosis. The medication that could help ...
Posted by Michael Wonder on 02 Dec 2023
Italfarmaco Group announces new PDUFA date for givinostat DMD NDA
29 November 2023 - Italfarmaco Group announced today that the US FDA has extended the review process of the n ...
Posted by Michael Wonder on 02 Dec 2023
Updates to the HTA Policy and Methods Review Reference Committee (1 December 2023)
1 December 2023 - To ensure that the Reference Committee has sufficient time to consider the extensive and valuable input ...
Posted by Michael Wonder on 01 Dec 2023
New frontier will lead to better health outcomes
30 November 2023 - The Government has today tabled its response to an inquiry considering how to give Australian patients timely ...
Posted by Michael Wonder on 20 Nov 2023
NICE gets ready to assess new dementia treatments
20 November 2023 - NICE’s methods and processes for evaluating new treatments for use in the NHS are appropriate for the ...
Posted by Michael Wonder on 15 Nov 2023
To get things done fast at FDA: ‘don’t tell anybody,’ cancer chief says
15 November 2023 - The FDA’s top cancer drug regulator doesn’t always ask for permission before taking on big initiatives. ...
Posted by Michael Wonder on 02 Nov 2023
Supernus announces SPN-830 apomorphine infusion device NDA accepted for review by FDA
2 November 2023 - PDUFA target action date of 5 April 2024. ...
Posted by Michael Wonder on 18 Oct 2023
Mirum Pharmaceuticals announces new PDUFA date for Livmarli for the treatment of cholestatic pruritus in progressive familial intrahepatic cholestasis
17 October 2023 - Mirum Pharmaceuticals today announced that the US FDA has extended the review of the supplemental new drug ...
Posted by Michael Wonder on 16 Oct 2023
EU delays approval of Novavax's revised COVID vaccine
16 October 2023 - European Union regulators have delayed a decision to give approval for Novavax's variant-tailored COVID-19 vaccine, the ...
Posted by Michael Wonder on 11 Oct 2023
Will Medicare price negotiation delay cancer drug launches?
11 October 2023 - On 29 August 2023, the Biden administration announced the first 10 drugs selected for Medicare price ...