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RSS FeedPosted by Michael Wonder on 15 Jun 2023
Amneal receives NDA approval from FDA for Pemrydi RTU, a ready to use oncology injectable
14 June 2023 - Adds first ready to use presentation of key injectable for treating non-squamous non-small cell lung cancer and ...
Posted by Michael Wonder on 14 Jun 2023
Ipsen announces US FDA submission acceptance of its supplemental new drug application for Onivyde regimen in first-line metastatic pancreatic ductal adenocarcinoma
14 June 2023 - Supplemental new drug application submission based on the NAPOLI 3 Phase 3 trial. ...
Posted by Michael Wonder on 12 Jun 2023
Phathom Pharmaceuticals announces FDA acceptance of NDA resubmission for erosive GERD
12 June 2023 - PDUFA goal date of 17 November 2023. ...
Posted by Michael Wonder on 12 Jun 2023
Capivasertib in combination with Faslodex granted priority review in the US for patients with advanced hormone receptor positive breast cancer
12 June 2023 - Decision based on CAPItello-291 Phase 3 trial results which showed the combination reduced the risk of ...
Posted by Michael Wonder on 09 Jun 2023
FDA accepts biologics license applications for exagamglogene autotemcel (exa-cel) for severe sickle cell disease and transfusion-dependent beta thalassaemia
8 June 2023 - FDA grants priority review for severe sickle cell disease and standard review for transfusion-dependent beta thalassemia. ...
Posted by Michael Wonder on 08 Jun 2023
Novaliq announces FDA approval of Vevye (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease
8 June 2023 - Vevye is the first and only cyclosporine solution indicated for the treatment of signs and symptoms ...
Posted by Michael Wonder on 08 Jun 2023
SAR443579/IPH6101 receives FDA fast track designation in the US for the treatment of haematological malignancies
8 June 2023 - SAR443579, ANKET platform lead asset, is a trifunctional anti-CD123 NKp46×CD16 NK cell engager from a joint research ...
Posted by Michael Wonder on 08 Jun 2023
FDA accepts application for Merck’s Keytruda (pembrolizumab) plus chemotherapy as treatment for advanced or unresectable biliary tract cancer
8 June 2023 - Acceptance based on results from the Phase 3 KEYNOTE-966 trial, which showed a significant overall survival ...
Posted by Michael Wonder on 07 Jun 2023
Legend Biotech announces submission of supplemental application to the US FDA for expanded use of Carvykti (ciltacabtagene autoleucel)
6 June 2023 - The application is supported by the Phase 3 CARTITUDE-4 study, which showed significant improvement in primary endpoint ...
Posted by Michael Wonder on 06 Jun 2023
Vyluma announces FDA acceptance of new drug application for NVK002, its novel investigational treatment for paediatric myopia
6 June 2023 – Vyluma announced today that the US FDA has accepted for review the new drug application for ...
Posted by Michael Wonder on 06 Jun 2023
GSK receives US FDA file acceptance for Jemperli (dostarlimab) plus chemotherapy for the treatment of dMMR/MSI-H primary advanced or recurrent endometrial cancer
6 June 2023 - Submission accepted for Priority Review. ...
Posted by Michael Wonder on 06 Jun 2023
SpringWorks Therapeutics announces PDUFA date extension for nirogacestat NDA
5 June 2023 - FDA extending PDUFA date by three months to allow more time to complete their review; new ...
Posted by Michael Wonder on 06 Jun 2023
Injectafer approved in the US for the treatment of iron deficiency in adult patients with heart failure
5 June 2023 - Injectafer is now the first and only intravenous iron replacement therapy indicated for adult patients with heart ...
Posted by Michael Wonder on 02 Jun 2023
Esperion announces submission of supplemental new drug applications to US FDA for Nexletol (bempedoic acid) tablet and Nexlizet (bempedoic acid and ezetimibe) tablet
1 June 2023 - Submitted four efficacy supplements seeking inclusion of cardiovascular disease risk reduction and expansion of LDL-cholesterol lowering. ...
Posted by Michael Wonder on 30 May 2023
Janssen submits new drug application to US FDA seeking approval of investigational single tablet combination therapy of macitentan and tadalafil for treatment of patients with pulmonary arterial hypertension
30 May 2023 - This is the first and only single tablet combination therapy application to be submitted for review in ...