FDA/CDC
News from the FDA/CDC
FDA approves Xyrem to treat children with narcolepsy
The central nervous system depressant was approved for the treatment of cataplexy and excessive daytime sleepiness.
FDA/CDC
Emgality approved for migraine prevention in adults
The calcitonin gene–related peptide antagonist was tested in both episodic and chronic migraine.
FDA/CDC
FDA review supports Nuplazid’s safety
FDA/CDC
FDA warns kratom vendors about unproven claims
The substance is already outlawed in several countries and banned in some states.
FDA/CDC
FDA approves Cassipa for opioid dependence
FDA/CDC
Janssen submits NDA for esketamine nasal spray
Esketamine has shown promise in treating refractory depression when used with an oral antidepressant.
FDA/CDC
FDA allows marketing of TMS to treat OCD
Transcranial magnetic stimulation already is approved to treat refractory major depression and migraine with aura.
FDA/CDC
CDC: 2017 worst year yet for drug overdoses
Deaths tied to synthetic opioids climbed faster than any other drug class.
FDA/CDC
FDA proposes broader outcomes for OUD treatment drug approvals
Draft guidance supports various clinical endpoints, including changes in drug use patterns other than the endpoint of abstinence.
FDA/CDC
FDA approves Perseris for schizophrenia
The drug achieved clinically relevant levels without the need for a loading or supplemental doses.
FDA/CDC
Fluoroquinolones can cause fatal hypoglycemia, FDA warns