If prescribed opioids for pain, ask lots of questions: FDA

(HealthDay)—If your doctor prescribes opioid painkillers such as hydrocodone, oxycodone, codeine or morphine for you, there are a number of questions you should ask, the U.S. Food and Drug Administration advises. Opioids can be used to treat certain kinds of acute and chronic pain, but can have some serious side effects, most notably addiction. If you’re prescribed opioids, the FDA […]

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FDA may approve emergency use of Ebola drug remdesivir TODAY

BREAKING NEWS: FDA may approve emergency use authorization of Ebola drug remdesivir TODAY after Dr Fauci called early results of one study ‘very optimistic’ The FDA may announce its decision allowing emergency use authorization of an antiviral remdesivir for coronavirus patients as early as Wednesday It comes as Gilead Sciences treated 397 severely ill patients and found  more than half of […]

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Teva Announces FDA Approval of Ajovy (fremanezumab-vfrm) Injection Autoinjector

PARSIPPANY, N.J.–(BUSINESS WIRE) January 28, 2020 — Teva Pharmaceuticals USA, Inc. an affiliate ofTeva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the Food and Drug Administration (FDA) has approved an autoinjector device for Ajovy® (fremanezumab-vfrm) injection. “The approval of the Ajovy autoinjector is another important step forward for Teva and the migraine community,” said Brendan O’Grady, executive […]

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FDA gives first Ebola vaccine for adults the green light

(HealthDay)—The first Ebola vaccine approved by the U.S. Food and Drug Administration is a single-dose injection called Ervebo. The vaccine from Merck & Co. is approved to protect against the Zaire ebolavirus in people ages 18 years and older. In the United States, Ebola infections are rare. Confirmed cases have involved people in other countries who became infected and then […]

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FDA urged to investigate use of unapproved anti-opioid implant on prisoners and the homeless

BioCorRx bills itself as a developer of “advanced solutions” for alcohol and opioid addictions. But the California-based company has come under fire for plans to test an unapproved naltrexone implant on Louisiana prison inmates and homeless Philadelphians who are struggling with addiction, in violation of federal laws protecting human research subjects. Only one prisoner actually received the implant before the […]

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FDA shelves plan to cut nicotine to 'non-addictive' levels in cigs

US regulators drop plans to cap nicotine levels in cigarettes to non-addictive levels just hours after Trump’s FDA nominee says he will not ban flavored e-cigs In 2017, then-FDA commissioner Scott Gottlieb proposed a plan cutting nicotine in cigarettes to minimally or ‘non-addictive’ levels The plan was on a bi-annual list of regulations the agency said it would be working […]

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Is LASIK Surgery Safe? A Former FDA Adviser Raises Doubts—But Here's What Eye Docs Have to Say

Millions of Americans have had LASIK eye surgery to correct their vision, but a retired adviser who was on the FDA committee that approved the procedure in 1996 is calling for it to be banned. According to Morris Waxler, PhD, LASIK has left many people with bad vision, and even driven some to suicide. “Essentially we ignored the data on […]

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Novartis C.E.O. Defends Company’s Decision to Withhold False Data From the F.D.A.

The chief executive of Novartis on Wednesday defended the company’s decision to delay telling the Food and Drug Administration about manipulated data involving its $2.1 million gene therapy treatment, saying that it “thoroughly, aggressively” investigated the issue and that patient safety was never threatened. Vas Narasimhan, the chief executive, also indicated in a call with investors that the company was […]

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