Ouster of Vinay Prasad, top FDA official
Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and ...
Tag: FDA
Two easy ways for the FDA to improve transparency
The U.S. Food and Drug Administration was slammed recently for overhyping its disclosure of a set of rejection notices it ...
New CDER director at FDA, how rescissions affect health policy
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 ...
Conservative politicians using flawed abortion-pill report to attack FDA
For decades, the Food and Drug Administration has partnered with clinicians and industry to deliver evidence-based medical innovations using a ...
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 ...
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 ...
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