Regulatory
The FDA recently approved the combination of Imbruvica-Rituximab for treating chronic lymphocytic leukemia. Here’s everything you need to know.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 22, 2020.
Futura Medical plc, a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® technology and currently focused on sexual health and pain, is pleased to announce that it has now filed for a further pre-submission meeting with the US FDA following receipt of the complete and signed clinical study report for its Phase 3 Study.
It does not require healthcare workers and first responders to conduct the test using personal protective equipment. Therefore, it should prevent the risk of transmitting the virus.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 21, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 20, 2020.
The U.S. Food and Drug Administration (FDA) approved Incyte’s Pemazyre (pemigatinib) for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.
Tukysa came out of Project Orbis, a multinational partnership between the FDA, the Australian Therapeutic Goods Administration, Health Canada, Health Sciences Authority and Swissmedic.
Here’s a look at what’s on the U.S. Food and Drug Administration’s schedule for the next two weeks.
The agency issued a statement saying that it will continue its activities, such as reviewing new drug applications and clinical trial, both COVID-19 and non-COVID-19, applications, “as we do everything possible to maintain continuity of operations in a very dynamic situation.”
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