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RSS FeedPosted 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 14 Jan 2020
Basket cases: how real-world testing for drugs approved based on basket trials might lead to false diagnoses, patient risks, and squandered resources
14 January 2020 - Basket trials, studies designed to assess the safety and efficacy of therapeutics targeted to a specific molecular ...
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 10 Jan 2020
Blueprint Medicines initiates rolling NDA submission to FDA for pralsetinib for the treatment of patients with RET fusion positive non-small cell lung cancer
8 January 2020 - Expect to complete NDA rolling submission for RET fusion-positive non-small cell lung cancer in Q1 2020. ...
Posted by Michael Wonder on 09 Jan 2020
FDA approves the first targeted therapy to treat a rare mutation in patients with gastro-intestinal stromal tumours
9 January 2020 - Today, the U.S. FDA approved Ayvakit (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal ...
Posted by Michael Wonder on 08 Jan 2020
FDA approves pembrolizumab for BCG-unresponsive, high-risk non-muscle invasive bladder cancer
8 January 2020 - On January 8, 2020, the Food and Drug Administration approved pembrolizumab (Keytruda) for the treatment of ...
Posted by Michael Wonder on 06 Jan 2020
BridgeBio Pharma’s QED Therapeutics receives fast track designation for infigratinib in adults with first-line advanced or metastatic cholangiocarcinoma and orphan drug designation for infigratinib for treatment of cholangiocarcinoma
6 January 2020 - The PROOF trial, a Phase 3 trial of infigratinib in first-line cholangiocarcinoma, is currently enrolling. ...
Posted by Michael Wonder on 31 Dec 2019
MorphoSys announces submission of biologics license application for tafasitamab in r/r DLBCL to the FDA
30 December 2019 - MorphoSys announced today that it has submitted a biologics license application to the U.S. FDA for tafasitamab, ...
Posted by Michael Wonder on 30 Dec 2019
Lynparza approved in the US as a first-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer
30 December 2019 - Only PARP inhibitor approved in germline BRCA-mutated metastatic pancreatic cancer. ...
Posted by Michael Wonder on 26 Dec 2019
Immunomedics announces FDA acceptance for filing of biologics license application resubmission for sacituzumab govitecan to treat metastatic triple-negative breast cancer
26 December 2019 - Prescription Drug User Fee Act target action date set for 2 June 2020. ...
Posted by Michael Wonder on 24 Dec 2019
Seattle Genetics announces submission of tucatinib new drug application to the U.S. FDA for patients with locally advanced or metastatic HER2 positive breast cancer
23 December 2019 - Submission based on positive pivotal HER2CLIMB trial results recently oresented at the 2019 San Antonio Breast Cancer ...
Posted by Michael Wonder on 21 Dec 2019
FDA approves new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies
20 December 2019 - Today, the U.S. FDA granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with ...
Posted by Michael Wonder on 20 Dec 2019
MacroGenics announces submission of margetuximab biologics license application to U.S. FDA
19 December 2019 - MacroGenics today announced that the Company has submitted a biologics license application for margetuximab, an investigational, Fc-engineered, ...
Posted by Michael Wonder on 19 Dec 2019
UroGen Pharma announces FDA fling acceptance and priority review of U.S. new drug application for UGN-101
19 December 2019 - Potential for UGN 101 to be first non-surgical therapy for the treatment of low-grade upper tract urothelial ...
Posted by Michael Wonder on 19 Dec 2019
Epizyme submits new drug application to the U.S. FDA for tazemetostat for the treatment of patients with follicular lymphoma
18 December 2019 - Submission marks on-time execution of second submission for tazemetostat in 2019. ...