Food and Drug Administration (FDA)
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The drug is approved for use for management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, adjunctive therapy for partial-onset seizures in patients 17 years of age and older, fibromyalgia, and neuropathic pain associated with spinal cord injury.
The FDA approval marks the first for oral ulcers associated with Behçet’s Disease and the third for Otezla.
A federal judge ordered that information on sales of opioids up to the year 2013 could be released.
Phase 1/2 trial to be HOOKIPA’s first clinical trial in immuno-oncology
Although the American public, Congress and the Trump administration have pressed for meaningful legislation over drug pricing, time is running out this year.
The beginning of virtual clinical trials is going to be a game-changer. Why they are going to be game-changer? What changes will occur? Know it all here.
The FDA approval marks the first drug approved for Azurity, a company formed from the merger of CutistPharma and Silvergate.
Cellectar Biosciences, Inc. announced the U.S. Food and Drug Administration has granted Fast Track Designation for CLR 131 in relapsed or refractory Diffuse Large B-Cell Lymphoma.
CorMedix Inc. announced that it has received feedback from the U.S. FDA regarding the submitted statistical analyses of data and additional information requested by the FDA for the primary and secondary efficacy endpoints of the Company’s LOCK-IT-100 clinical study.
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