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 ...

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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. ...

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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. ...

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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 ...

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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 ...

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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 ...

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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. ...

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Supernus announces SPN-830 apomorphine infusion device NDA accepted for review by FDA

2 November 2023 - PDUFA target action date of 5 April 2024. ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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. ...

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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. ...

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