Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 11 Sep 2023
Aquestive Therapeutics receives FDA acceptance of new drug application for Libervant (diazepam) buccal film in paediatric patients and assignment of PDUFA date
11 September 2023 - PDUFA target goal date set for 28 April 2024. ...
Posted by Michael Wonder on 11 Sep 2023
Verona Pharma announces the US FDA has accepted the new drug application filing for ensifentrine for the maintenance treatment of COPD
11 September 2023 - PDUFA target action date of 26 June 2024. ...
Posted by Michael Wonder on 23 Aug 2023
Geron announces PDUFA date for imetelstat NDA in lower risk MDS
22 August 2023 - Geron Corporationtoday announced that the US FDA has assigned a standard review and a PDUFA action date ...
Posted by Michael Wonder on 14 Aug 2023
Valneva announces PDUFA date extension for Chikungunya virus vaccine candidate
14 August 2023 – Valneva today announced that the US FDA has revised the PDUFA action date for the biologics ...
Posted by Michael Wonder on 27 Jun 2023
UCB provides update on US FDA review of the biologics license application for bimekizumab
26 June 2023 - UCB today announced that the biologics license application for bimekizumab for the treatment of adults with ...
Posted by Michael Wonder on 22 Jun 2023
ARS Pharmaceuticals announces PDUFA date extension for neffy (intranasal epinephrine) for the treatment of allergic reactions (type 1), including anaphylaxis
20 June 2023 - Additional time needed for labelling and post-marketing requirements discussions; PDUFA date set for 19 September 2023. ...