UF Startup Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device Designation for JointMedica’s Polymotion® Hip Resurfacing System.
UF startup Dialectic Therapeutics, Inc. (Dialectic®), announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to DT2216 for the treatment of T-cell lymphoma.
Tampa company Morphogenesis, a UF startup, has received a “fast track” designation for its skin cancer vaccination from the United States Food and Drug Administration.
An anticancer drug developed by researchers from the University of Florida College of Pharmacy has become the first drug of its kind allowed to proceed to clinical trial by the U.S. Food and Drug Administration.
UF startup Dialectic Therapeutics, Inc., a Texas-based biotechnology company focused on creating innovative new technologies to treat cancer, announced that the U.S. Food and Drug Administration (FDA) has concluded that Dialectic may proceed with its clinical investigation for its lead product candidate, DT2216, a unique compound built using its proprietary and novel Antiapoptotic Protein Targeted Degradation (APTaD) technology.
Pear Therapeutics is teaming up with UF Innovate | The Hub startup etectRx in a "first of its kind" collaboration examining the use of digital pill solutions with prescription digital therapeutics (PDTs), the latter company announced. As part of the agreement, whose financial terms were not disclosed, the companies will work on developing up to two central nervous system product candidates combining PDTs and adherence sensors.
Doctors soon will have a new way to evaluate patients with concussions: a rapid blood test made by Abbott Laboratories that has been cleared by the U.S. Food and Drug Administration. It’s an advancement that could eliminate the need for some patients to get costly CT scans and the radiation exposure that accompanies them.