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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 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 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 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 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 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 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 21 Sep 2023
Alvotech provides US regulatory update on AVT02, a high concentration interchangeable biosimilar candidate to Humira (adalimumab)
20 September 2023 - Alvotech announced today that the US FDA has accepted Alvotech’s resubmitted biologics license application for AVT02, a ...
Posted by Michael Wonder on 19 Sep 2023
UCB provides update on US regulatory review of bimekizumab
19 September 2023 - UCB today provided an update on the biologics license application for bimekizumab for the treatment of ...
Posted by Michael Wonder on 15 Sep 2023
US. FDA updates PDUFA action date for lifileucel for the treatment of advanced melanoma
14 September 2023 - FDA extends PDUFA date to 24 February 2024 on resource constraints and agrees to work with ...
Posted by Michael Wonder on 13 Sep 2023
Formycon announces file acceptance for FYB203, a biosimilar candidate to Eylea (aflibercept), by the US FDA
29 August 2023 - Formycon and its license partner Klinge Biopharma announce that the US FDA has accepted the biologics license ...