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RSS FeedPosted by Michael Wonder on 14 Feb 2020
Seattle Genetics announces FDA filing acceptance for priority review of tucatinib new drug application for patients with locally advanced or metastatic HER2-positive breast cancer
13 February 2020 - FDA Action Date is 20 August 2020; Application under FDA’s real-time oncology review and Orbis pilot programs. ...
Posted by Michael Wonder on 13 Feb 2020
U.S. FDA accepts for priority review Bristol-Myers Squibb’s biologics license application for lisocabtagene maraleucel (liso-cel) for adult patients with relapsed or refractory large B cell lymphoma
13 February 2020 - Application based on results from the TRANSCEND NHL 001 trial, the largest study of CD19-directed CAR T ...
Posted by Michael Wonder on 13 Feb 2020
NDA accepted for filing by the FDA for antisense oligonucleotide viltolarsen
7 February 2020 - Nippon Shinyaku announced today that the U.S. FDA has accepted the filing of our new drug ...
Posted by Michael Wonder on 13 Feb 2020
Deciphera Pharmaceuticals announces U.S. FDA acceptance of new drug application and priority review for ripretinib in patients with advanced gastro-intestinal stromal tumour
12 February 2020 - FDA grants priority review and sets PDUFA date of 13 August 2020. ...
Posted by Michael Wonder on 11 Feb 2020
Novartis announces MET inhibitor capmatinib (INC280), the first potential treatment for METex14 mutated advanced non-small cell lung cancer, granted priority FDA review
11 February 2020 - Capmatinib review expected to be completed within six months. ...
Posted by Michael Wonder on 11 Feb 2020
U.S. FDA grants priority review for Kite’s KTE-X19 biologics license application in relapsed or refractory mantle cell lymphoma
10 February 2020 - If approved, Kite could be first company with multiple commercialised CAR T therapies. ...
Posted by Michael Wonder on 04 Feb 2020
FDA accepts for review supplemental new drug application for Recarbrio (imipenem, cilastatin, and relebactam) for the treatment of adults with hospital-acquired and ventilator-associated bacterial pneumonia
3 February 2020 - Filing receives priority review. ...
Posted by Michael Wonder on 29 Jan 2020
Lilly receives FDA priority review for the selpercatinib new drug application
29 January 2020 - Eli Lilly announced today that the U.S. FDA has granted priority review for the new drug application ...
Posted by Michael Wonder on 21 Jan 2020
US FDA grants priority review of belantamab mafodotin for patients with relapsed or refractory multiple myeloma
21 January 2020 - Belantamab mafodotin has potential to be the first anti-BCMA treatment available to patients. ...
Posted by Michael Wonder on 20 Jan 2020
Lynparza regulatory submission granted priority review in the US for HRR-mutated metastatic castration-resistant prostate cancer
20 January 2020 - Submission based on PROfound, the first positive Phase III trial testing a targeted treatment in biomarker-selected ...
Posted by Michael Wonder on 17 Jan 2020
Fortress Biotech announces rare paediatric disease designation for CUTX-101 for the treatment of Menkes disease
16 January 2020 - Cyprium Therapeutics, a Fortress partner company, on track to begin submitting rolling new drug application for CUTX-101 ...
Posted by Michael Wonder on 15 Jan 2020
Clovis Oncology’s Rubraca (rucaparib) granted FDA priority review for advanced prostate cancer
15 January 2020 - FDA has assigned PDUFA date of 15 May 2020. ...
Posted by Michael Wonder on 15 Jan 2020
U.S. FDA accepts for priority review Bristol-Myers Squibb’s application for Opdivo (nivolumab) plus Yervoy (ipilimumab) in first-line non-small cell lung cancer
15 January 2020 - Application based on results from Part 1 of Phase 3 CheckMate-227 study. ...
Posted by Michael Wonder on 13 Jan 2020
Lynparza regulatory submission granted priority review in the US for first-line maintenance treatment with bevacizumab in advanced ovarian cancer
13 January 2020 - Submission based on Phase III PAOLA-1 trial for patients with advanced ovarian cancer regardless of biomarker ...
Posted by Michael Wonder on 09 Jan 2020
Aruvant receives FDA rare paediatric disease designation for ARU-1801 for the treatment of sickle cell disease
8 January 2020 - ARU-1801 is being developed as a potential one-time treatment for patients suffering from sickle cell disease and ...