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RSS FeedPosted by Michael Wonder on 20 Jun 2023
Geron announces submission of new drug application to FDA for first in class telomerase inhibitor imetelstat
20 June 2023 - Geron today announced the submission to the US FDA of a new drug application for imetelstat for ...
Posted by Michael Wonder on 20 Jun 2023
Legacy Healthcare announces EMA validation of marketing authorisation application for coacillium for the treatment of moderate and severe alopecia areata in children and adolescents
19 June 2023 - Legacy Healthcare today announced that its marketing authorisation application to the EMA's CHMP for Coacillium for the ...
Posted by Michael Wonder on 16 Jun 2023
Chugai files new drug application in Japan for crovalimab for paroxysmal nocturnal hemoglobinuria
16 June 2023 - The application was submitted based on several studies, including the global Phase 3 clinical studies COMMODORE 2 ...
Posted by Michael Wonder on 16 Jun 2023
GSK announces extension of FDA review period for momelotinib
16 June 2023 - GSK today announced that the US FDA has extended the review period of the new drug application ...
Posted by Michael Wonder on 16 Jun 2023
Takeda and HUTCHMED announce marketing authorisation application of fruquintinib for previously treated metastatic colorectal cancer validated by the European Medicines Agency
15 June 2023 - Application Includes Data from Phase 3 FRESCO-2 and FRESCO Clinical Trials, which Demonstrated Superiority of Fruquintinib Plus ...
Posted by Michael Wonder on 15 Jun 2023
FDA accepts for review Medexus's IXinity supplemental biological license application for paediatric patients
15 June 2023 - Expanded indication would cover patients 12 years of age or younger, a population that comprises approximately ...
Posted 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
Is Canada missing out? An assessment of drugs approved internationally between 2016 and 2020 and not submitted for Health Canada review
12 June 2023 - One-third of the new active substances approved in the United States and Europe between 2016 and ...
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
Astellas submits new drug application for zolbetuximab in Japan
9 June 2023 - Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced ...
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 ...