22 August 2023 - Geron Corporationtoday announced that the US FDA has assigned a standard review and a PDUFA action date ...
14 August 2023 – Valneva today announced that the US FDA has revised the PDUFA action date for the biologics ...
26 June 2023 - UCB today announced that the biologics license application for bimekizumab for the treatment of adults with ...
20 June 2023 - Additional time needed for labelling and post-marketing requirements discussions; PDUFA date set for 19 September 2023. ...
16 June 2023 - GSK today announced that the US FDA has extended the review period of the new drug application ...
5 June 2023 - FDA extending PDUFA date by three months to allow more time to complete their review; new ...
20 April 2023 - Daiichi Sankyo today announced that the US FDA has extended the review period for the new ...
7 March 2023 - FDA extends PDUFA target action date to 30 June 2023. ...
24 February 2023 - Celltrion has come forward to explain reasons for the delayed approval of its Humira biosimilar, Yuflyma ...
20 February 2023 - Astellas Pharma today announced the US FDA notified the company that it is extending the original priority ...
17 February 2023 - Eisai anticipates about 100,000 patients diagnosed will be eligible for the drug by year three of its ...
27 January 2023 - argenx today announced that the US FDA has extended the review of the biologics license application ...
9 January 2023 - Krystal Biotech today announced that on 5 January 2023, the US FDA notified the Company that ...
22 December 2022 - US FDA has confirmed that the goal date for an approval decision on Alvotech’s license application for ...
20 December 2022 - Pfizer oral treatment remains available to eligible US patients under emergency use authorisation as a critical ...