Blog
RSS FeedPosted 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
PharmaMar and Luye Pharma announce the acceptance of new drug application for lurbinectedin in China
6 June 2023 - PharmaMar and Luye Pharma have announced today that the new drug application submission of lurbinectedin has been ...
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
Daratumumab with bortezomib and dexamethasone for previously treated multiple myeloma
6 June 2023 - NICE has published evidence-based recommendations for daratumumab (Darzalex) for use in combination with bortezomib and dexamethasone ...
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 05 Jun 2023
NMPA accepted Akeso's ebronucimab (PCSK9) marketing application in two cardiovascular indications
1 June 2023 - Akeso announced today that China's NMPA has accepted its new drug application for its fully human anti-PCSK9 ...
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
Valneva files for Chikungunya vaccine authorisation with Health Canada
30 May 2023 - Valneva today announces the filing of a regulatory application with Health Canada for marketing approval of ...
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 ...
Posted by Michael Wonder on 30 May 2023
US FDA accepts for priority review Bristol Myers Squibb’s application for repotrectinib for the treatment of patients with locally advanced or metastatic ROS1 positive non-small cell lung cancer
30 May 2023 - BMS today announced that the US FDA has accepted the new drug application for repotrectinib, a ...
Posted by Michael Wonder on 26 May 2023
Janssen seeks European Commission approval of a new indication for Carvykti (ciltacabtagene autoleucel; cilta-cel) for the earlier treatment of patients with relapsed and refractory multiple myeloma
25 May 2023 - Application to the EMA is supported by data from the Phase 3 CARTITUDE-4 study, which evaluated the ...
Posted by Michael Wonder on 25 May 2023
Sandoz marketing authorisation applications for proposed biosimilar denosumab accepted by EMA
25 May 2023 - Submissions supported by comprehensive analytical and clinical data package including a Phase I PK/PD similarity study and ...