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RSS FeedPosted by Michael Wonder on 26 Jan 2024
European Medicines Agency validates type II variation application for Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer
26 January 2024 - Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival. ...
Posted by Michael Wonder on 24 Jan 2024
UroGen initiates submission of a rolling NDA to the FDA for UGN-102
24 January 2024 - UroGen Pharma today announced the submission of the Chemistry, Manufacturing, and Controls section of the new drug ...
Posted by Michael Wonder on 23 Jan 2024
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 ...
Posted 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 12 Jan 2024
Health Canada grants priority review status of ViiV Healthcare's new drug submission for cabotegravir long-acting injectable and tablets for prevention of HIV
10 January 2024 - Application is supported by data from the pivotal Phase 2b/3 studies evaluating safety and efficacy of long-acting ...
Posted by Michael Wonder on 11 Jan 2024
Arcutis Canada announces Health Canada acceptance of the supplement to a new drug submission for roflumilast 0.3% foam for the treatment of seborrheic dermatitis in individuals 9 years of age and older
8 January 2024 - Supplement to a new drug submission supported by positive Phase 2 and Phase 3 pivotal trial ...
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. ...