Blog
RSS FeedPosted by Michael Wonder on 15 May 2024
Ascendis Pharma announces extension of US FDA review period for TransCon PTH for adults with hypoparathyroidism
14 May 2024 - PDUFA goal date extended by three months for further review of submission to 14 August 2024. ...
Posted by Michael Wonder on 14 May 2024
Effect of Project Orbis participation by the Swiss regulator on submission gaps, review times, and drug approval decisions between 2020 and 2022: a comparative analysis
13 May 2024 - Expedited market access for novel and efficacious drugs is warranted for patients. Since 2020, Swissmedic (The Swiss ...
Posted by Michael Wonder on 12 May 2024
Moderna announces update on investigational RSV vaccine
10 May 2024 - US FDA has informed Moderna that due to administrative constraints, the agency will not complete its review ...
Posted by Michael Wonder on 19 Apr 2024
Publication of Stage 1 and Stage 2 PBS Process Improvements metrics report for 2022-23
19 April 2024 - The 2022-23 Stage 1 and Stage 2 PBS process improvements metrics report is now available on ...
Posted by Michael Wonder on 15 Apr 2024
Updates to the HTA Policy and Methods Review Reference Committee (15 April 2024)
15 April 2024 - The HTA Review Reference Committee is finalising its report and recommendations to the Australian Government having ...
Posted by Michael Wonder on 12 Apr 2024
Waiting for new medicines in Canada, Europe, and the United States: study finds Americans get better and faster access to innovative drugs
11 April 2024 - A recent study published by the Canadian Health Policy Institute examined the availability and wait times ...
Posted by Michael Wonder on 10 Apr 2024
New target zero initiative aims to help improve access to new drugs
9 April 2024 - Target Zero is a new initiative that aims to improve the time to access for patients ...
Posted by Michael Wonder on 27 Mar 2024
Patient advocates clash over wisdom of ‘approving drugs faster and faster’
26 March 2024 - Over 30 years ago, Gregg Gonsalves and other AIDS activists persuaded Congress to create the accelerated ...
Posted by Michael Wonder on 23 Mar 2024
Deliberations at the CHMP regarding the marketing authorisation application in the EU for lecanemab have been rescheduled due to procedural reasons at the EMA
22 March 2024 - Eisai announced today that the oral explanation scheduled for 19 March at the CHMP for lecanemab, ...
Posted 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 ...