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RSS FeedPosted by Michael Wonder on 23 Jan 2024
Autolus Therapeutics announces acceptance of biologics license application for obecabtagene autoleucel as a potential treatment for relapsed/refractory adult B-cell acute lymphoblastic leukaemia
22 January 2024 - PDUFA goal date is 16 November 2024. ...
Posted by Michael Wonder on 22 Jan 2024
Botannix Pharmaceuticals’ resubmission of Sofdra NDA accepted by FDA
22 January 2024 - Botannix Pharmaceuticals’ resubmission of the new drug application for Sofdra has been accepted by the FDA ...
Posted by Michael Wonder on 18 Jan 2024
UtilityTherapeutics announces FDA acceptance of PIVYA new drug application with priority review
17 January 2024 - Utility has received a Prescription Drug User Fee Act target action date of 24 April 2024. ...
Posted by Michael Wonder on 14 Jan 2024
Shorla Oncology announces FDA filing acceptance of new drug application for novel formulation to treat breast and ovarian cancer
9 January 2024 - Shorla Oncology announced today that the US FDA has accepted for review the company’s new drug application ...
Posted by Michael Wonder on 10 Jan 2024
Tivdak supplemental biologics license application accepted for priority review by FDA for patients with recurrent or metastatic cervical cancer
9 January 2024 - Submission based on positive results from global Phase 3 study demonstrating overall survival benefit of TIVDAK ...
Posted by Michael Wonder on 09 Jan 2024
Zevra Therapeutics receives FDA acceptance of resubmission of NDA for arimoclomol as a treatment for Niemann-Pick disease type C
8 January 2024 - Arimoclomol NDA has been assigned a PDUFA action date of 21 June 2024. ...
Posted by Michael Wonder on 08 Jan 2024
Journey Medical Corporation submits new drug application to FDA for DFD-29 to treat rosacea
5 January 2024 - NDA submission supported by positive Phase 3 clinical data. ...
Posted by Michael Wonder on 05 Jan 2024
Accord BioPharma announces US FDA acceptance of biologics license application for proposed Stelara biosimilar DMB-3115
4 January 2024 - Biosimilar for Stelara (ustekinumab) seeks to treat several auto-immune disorders caused by overactive immune response. ...
Posted by Michael Wonder on 04 Jan 2024
Applied Therapeutics announces MAA validation and NDA submission of govorestat (AT-007) for treatment of classic galactosaemia
3 January 2024 - Submissions are based on positive results from Phase 3 registrational ACTION-Galactosemia Kids study demonstrating consistent long-term ...
Posted by Michael Wonder on 03 Jan 2024
Theratechnologies submits sBLA for Trogarzo intramuscular method of administration to FDA
2 January 2024 - Submission comes on the heels of the recent FDA approval of the Trogarzo intravenous push loading dose. ...
Posted by Michael Wonder on 29 Dec 2023
Medytox submits BLA for non-animal-derived liquid BTX formulation in US
28 December 2023 - Medytox said it has submitted a biologics license application to the US FDA for MT10109L, a ...
Posted by Michael Wonder on 28 Dec 2023
Resubmission of arimoclomol new drug application to the US FDA
27 December 2023 - Zevra Therapeutics today announced it resubmitted its new drug application for arimoclomol, an investigational therapeutic candidate for ...
Posted by Michael Wonder on 28 Dec 2023
Milestone Pharmaceuticals receives refusal to file letter from US FDA for new drug application for etripamil in the treatment of PSVT
26 December 2023 - Milestone Pharmaceuticals announced today that the Company received a refusal to file letter from the US ...
Posted by Michael Wonder on 27 Dec 2023
US FDA issues complete response letter for dasiglucagon in congenital hyperinsulinism for up to three weeks of dosing due to inspection findings at third-party manufacturing facility
23 December 2023 - The complete response letter is related to deficiencies identified at a third-party manufacturing facility following an inspection ...
Posted by Michael Wonder on 27 Dec 2023
Amgen provides regulatory update on the status of Lumakras (sotorasib)
26 December 2023 - FDA has issued a new post-marketing requirement. ...