The U.S. Food & Drug Administration declined to approve two China-tested cancer treatments on Monday, saying one of the companies – Hutchmed Ltd. – needs to test its drug for the U.S. population in a diverse multi-regional trial.
The American Society of Clinical Oncology (ASCO) 2020 meeting was held virtually this year due to the COVID-19 pandemic and included hundreds of abstracts, posters and presentations.
The U.S. Food and Drug Administration approved Deciphera Pharmaceuticals Inc.’s Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
Despite the COVID-19 pandemic, the U.S. Food and Drug Administration has managed to stay fairly on track in terms of evaluating new drug and supplemental new drug applications. Here is a look at what is on the schedule for the next two weeks.
The U.S. Food and Drug Administration granted Priority Review to Deciphera Pharmaceuticals’ ripretinib as an investigational treatment for advanced gastrointestinal stromal tumors (GIST).
Although January 2020 was a fairly slow month for PDUFA dates for the U.S. Food and Drug Administration, February has a stronger schedule.
The U.S. Food and Drug Administration approved Blueprint Medicines Corp.’s oral therapy to treat a rare form of cancer that affects the stomach and small intestine.
AstraZeneca is significantly expanding the company’s footprint in China with the establishment of a global R&D center and launch of a $1 billion fund aimed at supporting that nation’s healthcare sector.