Regulatory
August is a busy month on the U.S. Food and Drug Administration (FDA)’s calendar. Here’s a look at this week’s schedule.
The U.S. FDA issued a new template for clinical test developers that is designed to assist these companies in developing and submitting emergency use authorization (EUA) for COVID-19 tests that can be performed at home or in other settings besides laboratories.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 31, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 29, 2020.
The U.S. House of Representatives approved a $3.2 billion budget proposal for the U.S. Food and Drug Administration (FDA) that will boost the agency’s abilities to approve new medicines and medical devices, as well as protect the nation’s food supplies.
The IGNITE DMD study is assessing the company’s microdystrophin gene therapy asset SGT-001 as a potential treatment for DMD.
The U.S. Food and Drug Administration (FDA) approved Kite Pharma’s Tecartus (brexucabtagene autoleucel) for adults with relapsed or refractory mantle cell lymphoma (MCL). Kite is a Gilead Science company.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 27, 2020.
The Prescription Drug User Fee Act (PDUFA) was first passed into law by the U.S. Congress in 1992.
This morning, AstraZeneca announced the approval of the triple-therapy Breztri Aerosphere as a maintenance treatment for COPD.
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