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The U.S. Food and Drug Administration on Monday approved Gamifant (emapalumab-lzsg) for the treatment of primary hemophagocytic lymphohistiocytosis (HLH) in pediatric (as young as newborn) and adult patients who have refractory

FDA Approves Drug to Treat Rare Immune Disease

Gamifant first drug to be approved specifically for primary hemophagocytic lymphohistiocytosis
The U.S. Food and Drug Administration on Friday expanded approval for the use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with specific types of peripheral T-cell lymphoma.

FDA Approves First-Line Tx for Peripheral T-Cell Lymphoma

Adcetris approved in combination with chemo to treat systemic anaplastic large cell lymphoma
The U.S. Food and Drug Administration said today it will take steps to limit or ban access to flavored electronic cigarettes

FDA Moves to Restrict Flavored E-Cig Sales, Ban Menthol Cigarettes

The move stops short of the full ban on e-cigarettes that had been expected
JUUL Labs

Under Pressure, JUUL Withdraws Most Flavored E-Cigs From Market

Company is also shutting down Facebook and Instagram accounts in the United States
As part of the U.S. Food and Drug Administration's efforts to reduce teens' use of flavored electronic cigarettes

FDA to Ban Most Flavored Electronic Cigarettes

Details of the ban expected to be announced next week
A new version of an over-the-counter asthma inhaler that was taken off the market in 2011 has been approved by the U.S. Food and Drug Administration.

FDA Approves New Version of OTC Primatene Mist

Primatene Mist approved to provide temporary relief for symptoms of mild, intermittent asthma
Ruling against the recommendation of one of its chief experts

FDA Approves Powerful New Opioid Despite Criticisms

Dsuvia use restricted to operating rooms or on the battlefield
Many supplements contain one or more stimulants that have been the subject of U.S. Food and Drug Administration-issued public notices

Most Supplements Contain Prohibited Stimulants

75 percent of supplements purchased in 2017 contained one or more stimulants subject to FDA notices
For the first time in nearly two decades

FDA Approves First New Influenza Drug in 20 Years

Antiviral drug reduces symptoms of uncomplicated influenza when taken within 48 hours of onset
Dietary supplements often include active pharmaceuticals

Active Pharmaceuticals ID’d in >700 Dietary Supplements

More than 20 percent of the 776 adulterated products contained more than one unapproved ingredient