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RSS FeedPosted 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
Cabaletta Bio receives additional FDA fast track designations for CABA-201 in dermatomyositis and systemic sclerosis
8 January 2024 - Second and third FDA fast track designations for CABA-201, following the systemic lupus erythematosus and lupus ...
Posted by Michael Wonder on 08 Jan 2024
FDA grants Soligenix fast track designation for dusquetide in the treatment of oral lesions of Behçet's disease
8 January 2024 - Soligenix announced today that its SGX945 (dusquetide) development program for the treatment of oral lesions of Behçet's ...
Posted by Michael Wonder on 08 Jan 2024
Novel drug approvals for 2023
8 January 2024 - Innovative drugs often mean new treatment options for patients and advances in health care for the American ...
Posted by Michael Wonder on 08 Jan 2024
US Food and Drug Administration approves Zelsumvi as a first in class medication for the treatment of molluscum contagiosum
5 January 2023 - Zelsumvi is expected to be commercially available during the second half of 2024. ...
Posted by Michael Wonder on 08 Jan 2024
Florida is first state allowed to import drugs from Canada in bid to reduce costs
5 January 2024 - FDA’s decision could change the way Americans obtain prescription medicines. ...
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
ProfoundBio announces rinatabart sesutecan FDA fast track designation for patients with advanced ovarian cancer
5 January 2023 - ProfoundBio today announced that the US FDA has granted fast track designation for rinatabart sesutecan (Rina-S; ...
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
2023 FDA approvals
2 January 2024 - The FDA’s Center for Drug Evaluation and Research approved 55 new drugs in 2023, as the small ...
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 01 Jan 2024
New medical treatments will use genetic scissors, and other clever tricks
13 November 2023 - New medicines to treat sickle cell disease and beta thalassaemia, two genetic blood disorders, will make headlines ...
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 ...