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RSS FeedPosted by Michael Wonder on 15 Aug 2023
Venatorx Pharmaceuticals announces FDA acceptance and priority review of new drug application for cefepime-taniborbactam to treat complicated urinary tract infections, including pyelonephritis, in adults
15 August 2023 - PDUFA action date set for 22 February 2024. ...
Posted by Michael Wonder on 14 Aug 2023
In the case of a devastating disease, the FDA weighs an experimental drug’s muddled data and a desperate need
14 August 2023 - Emma Albee knows the experimental drug she takes is not a cure. It won’t allow her ...
Posted by Michael Wonder on 14 Aug 2023
Valneva announces PDUFA date extension for Chikungunya virus vaccine candidate
14 August 2023 – Valneva today announced that the US FDA has revised the PDUFA action date for the biologics ...
Posted by Michael Wonder on 10 Aug 2023
US FDA accepts Astellas' sNDA for Cresemba (isavuconazonium sulphate) in children
10 August 2023 - Astellas announced that the US FDA has accepted the company's supplemental new drug application for Cresemba (isavuconazonium ...
Posted by Michael Wonder on 07 Aug 2023
Viatris and Mapi Pharma announce FDA acceptance of new drug application filing for glatiramer acetate depot for the treatment of relapsing forms of multiple sclerosis
7 August 2023 - FDA assigns PDUFA target action date of 8 March 2024. ...
Posted by Michael Wonder on 07 Aug 2023
FDA approves Zurzuvae (zuranolone), the first and only oral treatment approved for women with postpartum depression, and issues a complete response letter for major depressive disorder
4 August 2023 - Post partum depression approval based on results from two Phase 3 clinical trials; in the SKYLARK study ...
Posted by Michael Wonder on 05 Aug 2023
Basilea announces submission of a new drug application to the US FDA for its antibiotic ceftobiprole
4 August 2023 - Seeking approval for Staphylococcus aureus bacteraemia, acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. ...
Posted by Michael Wonder on 04 Aug 2023
Orchard Therapeutics completes submission of biologics license application for OTL-200 in MLD to US FDA
3 August 2023 - Four MLD patients identified from ~150,000 newborns screened in prospective studies suggests significantly higher incidence than previously ...
Posted by Michael Wonder on 04 Aug 2023
Mesoblast receives complete response from US FDA for biologics license application for steroid-refractory acute graft versus host disease in children
4 August 2023 - Mesoblast Limited today announced that the US FDA has provided a complete response to its biologics license ...
Posted by Michael Wonder on 31 Jul 2023
US FDA accepts biologics license application for GC Biopharma's GC5107B (immune globulin intravenous (human), 10% liquid)
31 July 2023 - GC Biopharma today announced that the US FDA has accepted the Company's resubmission of the biologics ...
Posted by Michael Wonder on 28 Jul 2023
Janssen submits supplemental new drug application to US FDA seeking expanded paediatric indication for HIV-1 therapy Edurant
28 July 2023 - Parallel application also submitted to European Medicines Agency. ...
Posted by Michael Wonder on 27 Jul 2023
Defender Pharmaceuticals announces submission of new drug application to FDA with intranasal scopolamine for prevention of nausea and vomiting induced by motion in adults
26 July 2023 - Submission based on five Phase III clinical trials, including overwhelmingly positive results from the -33 Phase 3 ...
Posted by Michael Wonder on 25 Jul 2023
US FDA accepts supplemental new drug application for Ofev (nintedanib) for children and adolescents aged 6-17 years old with fibrosing interstitial lung disease
25 July 2023 - The supplemental new drug application is based on results from the InPedILD Phase III trial, which assessed ...
Posted by Michael Wonder on 18 Jul 2023
Madrigal Pharmaceuticals completes submission of new drug application seeking accelerated approval of resmetirom for the treatment of NASH with liver fibrosis
17 July 2023 - Madrigal Pharmaceuticals announced the completion of the rolling submission of its new drug application to the US ...
Posted by Michael Wonder on 17 Jul 2023
Green Cross resubmits BLA for its immunoglobulin blood product to FDA
17 July 2023 - Green Cross said it has submitted a biologics license application to the US FDA for Alyglo, ...