FDA Turns Down Capricor Cell Therapy for Cardio Complications of Rare Muscle Disease
Capricor Therapeutics’ cell therapy for Duchenne muscular dystrophy has come up short at the FDA, with the regulator rejecting the ...
Tag: FDA
Mendaera gets FDA 510(k) clearance for handheld robotic system
Mendaera, a robotics company, announced it has been granted FDA 510(k) clearance for Focalist, a handheld robotic system, which aims ...
With FDA Nod in Lung Cancer, Dizal Now Aims to Best a J&J Drug and Succeed Where Takeda Fell Short
One of the more competitive targets in lung cancer is a certain mutation that has eluded many available targeted therapies. ...
Fasikl’s NeuroAI Wristband for essential tremor gains FDA clearance
Minneapolis-based Fasikl has received FDA 510(k) clearance for its Felix NeuroAI Wristband for adults with essential tremor. The wearable combines ...
FDA Approves Regeneron Multiple Myeloma Drug With Dosing Edge Over J&J and Pfizer Meds
Regeneron Pharmaceuticals is expanding its cancer drug lineup with FDA approval of a bispecific antibody it developed for multiple myeloma, ...
FDA clears Sora Neuroscience’s brain mapping software
Sora Neuroscience, a brain AI software company, announced it received FDA clearance for its Cirrus brain mapping software, which is ...
STAT+: Radical transparency at the FDA, and a pivotal moment for vaccines
You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign ...
FDA announces a new priority review program in bid to further administration goals
WASHINGTON — The Food and Drug Administration is launching a program to reward companies with accelerated drug review and speedy agency ...
FDA approval of pembrolizumab marks major shift in head and neck cancer treatment
Pembrolizumab, an immune checkpoint inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of ...
FDA approves pembrolizumab for resectable head and neck cancer with PD-L1 expression
Credit: Unsplash/CC0 Public Domain Pembrolizumab, an immune checkpoint inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) ...
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