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RSS FeedPosted by Michael Wonder on 07 Dec 2023
Ipsen confirms US FDA grants priority review for new drug application for elafibranor for the treatment of rare cholestatic liver disease, PBC
7 December 2023 - New drug application granted priority review with PDUFA date set for 10 June 2024. ...
Posted by Michael Wonder on 06 Dec 2023
BridgeBio Pharma announces submission of new drug application to US FDA for acoramidis for the treatment of patients with transthyretin amyloid cardiomyopathy
5 December 2023 - NDA submission is based on positive results from ATTRibute-CM Phase 3 study. ...
Posted by Michael Wonder on 06 Dec 2023
Neurocrine Biosciences receives breakthrough therapy designation from US FDA for crinecerfont in congenital adrenal hyperplasia
5 December 2023 - Crinecerfont new drug application submission planned in 2024. ...
Posted by Michael Wonder on 05 Dec 2023
US FDA accepts for priority review Bristol Myers Squibb’s application for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma
5 December 2023 - The US FDA assigned a target action date of 5 April 2024. ...
Posted by Michael Wonder on 05 Dec 2023
Vanda Pharmaceuticals announces that US FDA accepts new drug application for tradipitant for the treatment of gastroparesis
4 December 2023 - Vanda Pharmaceuticals today announced that the US FDA has accepted the filing of Vanda's new drug ...
Posted by Michael Wonder on 04 Dec 2023
Celltrion submits application for FDA approval of Prolia biosimilar CT-P41
4 December 2023 - Celltrion announced on 30 November (local time) that it has completed the application for product licensing ...
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 02 Dec 2023
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) for the first-line treatment of patients with locally advanced or metastatic urothelial cancer
30 November 2023 - Acceptance based on results from the Phase 3 KEYNOTE-A39 trial, which showed a statistically significant and ...
Posted by Michael Wonder on 30 Nov 2023
FDA grants priority review for supplemental biologics license application of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer
30 November 2023 - Results of pivotal confirmatory trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall survival and ...
Posted by Michael Wonder on 30 Nov 2023
Formycon and Fresenius Kabi announce file acceptance for FYB202, a biosimilar candidate to Stelara (ustekinumab), by the US FDA
30 November 2023 - Formycon and its commercialisation partner Fresenius Kabi today announced that the US FDA has accepted the biologics ...
Posted by Michael Wonder on 30 Nov 2023
FDA accepts Arcutis’ supplemental new drug application for roflumilast 0.15% cream for the treatment of atopic dermatitis in adults and children down to age 6
29 November 2023 - FDA has set a PDUFA target action date of 7 July 2024. ...
Posted by Michael Wonder on 29 Nov 2023
Karuna Therapeutics announces US FDA accepts new drug application for KarXT for the treatment of schizophrenia
29 November 2023 - PDUFA action date is 26 September 2024. ...
Posted by Michael Wonder on 28 Nov 2023
Orexo announces FDA acceptance of new drug application filing for OX124, a high-dose rescue medication for opioid overdose
28 November 2023 - PDUFA set to 15 July 2024. If approved, US launch is expected to be initiated late ...
Posted by Michael Wonder on 28 Nov 2023
Autolus Therapeutics submits biologics license application to US FDA for obecabtagene autoleucel (obe-cel) for patients with relapsed/refractory adult B-cell acute lymphoblastic leukaemia
27 November 2023 - BLA submission includes results from pivotal Phase 2 FELIX study evaluating obe-cel in relapsed/refractory adult B-cell acute ...
Posted by Michael Wonder on 28 Nov 2023
Abeona Therapeutics announces FDA accepts and grants priority review for Pz-cel biologics license application
27 November 2023 - PDUFA target action date is 25 May 2024. ...