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Aprea Therapeutics Announces FDA Clearance of IND for APR-1051, its Next Generation WEE1 Kinase Inhibitor for Cyclin E Overexpressing Cancers


today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application (IND 169359) for APR-1051. “APR-1051 is a next-generation inhibitor of ... Read More

Intuitive Announces FDA Clearance of Fifth-Generation Robotic System, da Vinci 5


“We are pleased to receive FDA clearance for our fifth-generation ... in the U.S. and its impact on hospital spending, reimbursement, and fees levied on certain medical device revenues; changes ... Read More

Butterfly Network Announces FDA Clearance of its Next-Generation Handheld Ultrasound System, Butterfly iQ3


today announced the FDA clearance of its next-generation handheld point-of-care ultrasound (POCUS) system, Butterfly iQ3. The new device is the company’s third iteration of the world’s first ... Read More

ADI Announces U.S. FDA 510(k) Clearance and the Commercial Launch of Sensinel by Analog Devices™ Cardiopulmonary Management (CPM) System


March 5, 2024 /PRNewswire/ -- Analog Devices, Inc. (Nasdaq: ADI) today announced U.S. Food and Drug Administration (FDA) 510(k) clearance ... CPM System is the next-generation solution for ... Read More

Intuitive Announces FDA Clearance of Fifth-Generation Robotic System, da Vinci 5


announced today that the U.S. Food and Drug Administration (FDA) provided 510(k) clearance for da Vinci 5, the company’s next-generation multiport robotic system. “We are pleased to receive ... Read More

Aprea Therapeutics Announces FDA Clearance of IND for APR-1051, its Next Generation WEE1 Kinase Inhibitor for Cyclin E Overexpressing Cancers


“APR-1051 is a next-generation inhibitor of WEE1 kinase and, based on its unique characteristics, we believe it will be best in class,” said Dr. Oren Gilad, President and CEO of Aprea. “The FDA's ... Read More


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