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RSS FeedPosted by Michael Wonder on 24 Dec 2022
Ipsen receives complete response letter for palovarotene, an investigational treatment for fibrodysplasia ossificans progressiva
23 December 2022 - The letter is related to the US FDA’s previous request for additional information on palovarotene clinical trial ...
Posted by Michael Wonder on 24 Dec 2022
Adaptimmune announces initiation of biologics license application submission for afami-cel, its first generation engineered TCR T-cell therapy targeting MAGE-A4, for the treatment of synovial sarcoma
23 December 2022 - Afami-cel has the potential to be the first approved engineered TCR T-cell therapy for a solid tumour. ...
Posted by Michael Wonder on 24 Dec 2022
Neurocrine Biosciences announces US FDA accepts supplemental new drug application for valbenazine as a treatment for chorea associated with Huntington disease
22 December 2022 - PDUFA target action date set for 20 August 2023. ...
Posted by Michael Wonder on 24 Dec 2022
Valneva completes BLA submission to US FDA for its single shot chikungunya vaccine candidate
23 December 2022 - Valneva today announces that it has completed rolling submission of the biologics license application to the ...
Posted by Michael Wonder on 23 Dec 2022
UCB announces FDA acceptance of BLA resubmission for bimekizumab
23 December 2022 - The FDA designated the BLA resubmission as ‘Class 2’ with a six month review period. ...
Posted by Michael Wonder on 22 Dec 2022
Update on US regulatory status of AVT02, Alvotech’s proposed high concentration, interchangeable biosimilar to Humira
22 December 2022 - US FDA has confirmed that the goal date for an approval decision on Alvotech’s license application for ...
Posted by Michael Wonder on 22 Dec 2022
US FDA extends review of Pfizer’s new drug application for Paxlovid
20 December 2022 - Pfizer oral treatment remains available to eligible US patients under emergency use authorisation as a critical ...
Posted by Michael Wonder on 22 Dec 2022
Aldeyra Therapeutics submits new drug application to the US FDA for ADX‑2191 for the treatment of primary vitreoretinal lymphoma
21 December 2022 - Aldeyra Therapeutics today announced the submission of a new drug application to the US FDA for ...
Posted by Michael Wonder on 21 Dec 2022
Pfizer announces FDA and EMA acceptance of etrasimod regulatory submissions for ulcerative colitis
21 December 2022 - Filings based on two Phase 3 trials demonstrating significant clinical remission versus placebo and safety profile ...
Posted by Michael Wonder on 21 Dec 2022
Idorsia submits a new drug application to the US FDA for aprocitentan for the treatment of patients with difficult to control hypertension
20 December 2022 - The application includes data from the Phase 3 registration trial of patients with resistant hypertension, where ...
Posted by Michael Wonder on 21 Dec 2022
Iveric Bio announces completion of rolling NDA submission to FDA for avacincaptad pegol for the treatment of geographic atrophy
20 December 2022 - Commercial launch preparations continue to accelerate. ...
Posted by Michael Wonder on 20 Dec 2022
Astellas, Seagen and Merck announce FDA acceptance of supplemental biologics license applications for Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) for the first-line treatment of certain patients with locally advanced or metastatic urothelial cancer
20 December 2022 - FDA granted the applications priority review with a PDUFA date of 21 April 2023. ...
Posted by Michael Wonder on 20 Dec 2022
F2G announces FDA filing acceptance of new drug application for Olorofim for the treatment of invasive fungal infections
19 December 2022 - Application submitted under priority review with PDUFA target action date set for 17 June 2023. ...
Posted by Michael Wonder on 20 Dec 2022
Albireo submits Bylvay Alagille syndrome regulatory filings to FDA and EMA
19 December 2022 - Gold standard Phase 3 ASSERT study supports supplementary filings in the US and EU. ...
Posted by Michael Wonder on 20 Dec 2022
HUTCHMED initiates rolling submission of NDA to US FDA for fruquintinib for the treatment of refractory colorectal cancer
19 December 2022 - Company plans to complete rolling submission to the US in the first half of 2023, followed by ...