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The FDA issued a complete response letter to Evoke Pharma for its Gimoti (metoclopramide) nasal spray for treatment of diabetic gastroparesis, a condition that delays emptying of the stomach. Read More
Dupixent is already approved for treatment of adults with moderate-to-severe eczema and for use with other asthma drugs for the maintenance treatment of moderate-to-severe asthma. Read More
The FDA revoked its breakthrough therapy designation for Tonix’s posttraumatic stress disorder drug Tonmya (cyclobenzaprine HCl sublingual tablets), citing disappointing interim data from a clinical trial. Read More