Food and Drug Administration (FDA)
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In a first of its kind ruling, the U.S. Food and Drug Administration approved GW Pharmaceuticals’ Epidiolex, a cannabis-based treatment for seizures associated with two rare forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome.
The U.S. Food and Drug Administration (FDA) accepted Merck’s new supplemental Biologics License Application (sBLA) for Keytruda.
AbbVie is taking another shot at solid tumor treatments through a collaboration with Calibr.
It’s a big week for the U.S. Food and Drug Administration (FDA) with plenty of upcoming decisions including Achaogen, GW Pharma, Merck and more.
The scope of the U.S. Food and Drug Administration’s mission could become much narrower if a proposed restructuring of the federal government comes to fruition.
A consumer advocacy group, Public Citizen, has petitioned the FDA to pull the drug, Uloric, off the market.
For type 1 narcolepsy, this sleep-wake instability is linked to low levels of hypocretin, also called orexin. Hypocretin is a neurotransmitter produced in the hypothalamus and has a significant role in wakefulness and regulating rapid eye movement (REM) sleep. But Harmony Biosciences has found another link, this one to histamine.
A new report highlights some concerns about the long-term commercial viability of game-changing gene therapies that can radically transform the lives of patients.
Purdue Pharma, best known for selling painkiller OxyContin, announced it laid off approximately 350 staffers.
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