Government Agencies FDA

  • Scott Gottlieb, former Commissioner of the FDA

    However, he says, that doesn't mean it won't cause harm. "You can't inhale something into the lungs on a repeated basis and not cause some damage."

  • Oct 11- British American Tobacco Plc unit Reynolds American Inc said on Friday it had filed for a review of its Vuse e-cigarettes by the U.S. Food and Drug administration, giving it a lead over its main rival Juul Labs Inc.. The FDA has set a May 2020 deadline for e-cigarette makers to submit a formal application to keep their products on the market amid its efforts to...

  • The U.S. Food and Drug Administration approved a drug to help prevent migraines on Thursday. The drug, Reyvow, was developed by Eli Lilly and Co. and has proven effective in alleviating the painful symptoms of migraines.

  • Oct 11- British American Tobacco Plc unit Reynolds American Inc said on Friday it had filed for a U.S. Food and Drug Administration review of its VUSE e-cigarettes. To regulate vape makers, the FDA last month proposed a rule, which, when finalized, will help ensure applications for marketing authorization of their products contain information on their potential...

  • A man uses a vape device in this illustration picture, September 19, 2019

    Almost all patients with a mysterious vaping-related lung disease have been hospitalized, with about half ending up in the intensive care unit, Centers for Disease Control and Prevention officials said Friday.

  • CNBC's Meg Tirrell reports on the latest details about Oxycontin maker Purdue Pharma's multiple fights in court.

  • A collection of popular vaping products include Suorin, Juul and Blu are displayed for Cheryl Phillips' presentation at St. Joseph Mercy Canton Health Center in Canton on Monday, Sept. 24, 2018. The U.S. Food and Drug Administration has announced a series of policies to attack what it calls "the epidemic use of electronic cigarettes and nicotine addiction among kids."

    The inspection comes as federal authorities combat two public health crises: one from vaping and the other due to opioids.

  • Oct 9- The U.S. Food and Drug Administration approved Australian drugmaker Clinuvel Pharmaceuticals Ltd's treatment for a rare inherited disorder that causes skin damage from exposure to light, sending its shares to a record high on Wednesday. "With the approved New Drug Application, Scenesse is the first global systemic photoprotective drug for the...

  • *Four products recalled; OTC ones not affected- UK regulator. Oct 8- GlaxoSmithKline on Tuesday said it is recalling the popular heartburn medicine Zantac in all markets as a "precaution", days after the U.S. Food and Drug Administration found "unacceptable" levels of probable cancer-causing impurity in the drug. Britain's medicines watchdog said...

  • Oct 8- The U.S. Food and Drug Administration said on Tuesday it approved Australian drugmaker Clinuvel Pharmaceuticals Ltd's treatment for a rare inherited disorder that results in skin damage from exposure to light. Scenesse is already approved in Europe since 2014 and is prescribed to patients through specialized treatment centers.

  • *Novartis wins FDA blessing for new eye drug. ZURICH, Oct 8- Novartis's anti-blindness medicine Beovu has become the latest eye drug to win U.S. Food and Drug Administration approval, giving the Swiss drugmaker a boost in the increasingly competitive market for eye problems among an ageing population. With the FDA's blessing, Beovu joins blockbuster...

  • Chairman Raja Krishnamoorthi (D-IL) (L) points to a poster showing similarities between Marlboro cigarette ads and JUUL Vaping paraphernalia, during a House Economic and Consumer Policy Subcommittee hearing that heard testimony on JUUL's Role in the youth nicotine epidemic, on July 25, 2019 in Washington, DC.

    Rep. Raja Krishnamoorthi, D-Ill., is introducing a bill that would cap the amount of nicotine in e-cigarettes as lawmakers seek to stem an "epidemic" of teen vaping.

  • Oct 7- The U.S. Food and Drug Administration on Monday approved a bone-building drug from Pfenex Inc to treat osteoporosis in certain patients at high risk for fractures, giving the company its first commercial product. Pfenex said it was conducting a comparative study between PF708 and Forteo and expects to submit a final report to the FDA as early as the second...

  • Altria's Iqos store in Atlanta's Lenox Square mall

    Iqos isn't a vaping device or a cigarette. It heats tobacco, but doesn't burn it, giving users the same rush of nicotine as smoking.

  • Oct 3- The U.S. Food and Drug Administration on Thursday approved Gilead Sciences Inc's Descovy to reduce the risk of sexually acquired HIV infection in men and transgender women who have sex with men. The company said on Thursday that its list price for both Truvada and Descovy is $1,758 per month. The FDA- approved label for Descovy, while more limited than...

  • A man checks in with a program manager after driving nearly three hours to get to his appointment at Open Arms Healthcare Center on Wednesday, January 23, 2019, in Jackson, MS. Open Arms provides PrEP, or Pre-exposure prophylaxis, which is "a way for people who do not have HIV but who are at substantial risk of getting it to prevent HIV infection by taking a pill every day," according to the CDC.

    The U.S. Food and Drug administration approved the second drug to prevent HIV infections on Thursday. Descovy, is a PrEP or pre-exposure prophylaxis drug.

  • Oct 2- The U.S. Food and Drug Administration and international health authorities are investigating the safety of Zantac heartburn medicine, also sold generically as ranitidine, after finding a probable cancer-causing impurity https://www.reuters.com/article/us-fda-heartburn/fda-says-finds-unacceptable-lev e l- o f- c a r c i n o g e n- i n- z a n t a c- a n d- i t s-...

  • Andy Ramkumar, who works at Gotham Vape in Queens, vapes at the store on September 17, 2019 in New York City.

    Researchers say "toxic chemical fumes," not oils as previously expected, may be the cause of a vaping illness that's killed at least 16 people since July.

  • The FDA, which checked the over-the-counter drugs using a low-heat method of testing, said it found much lower levels of the impurity- N-nitrosodimethylamine- than was discovered with a higher temperature test employed by Valisure. The FDA has since expanded its investigation of the impurities beyond that class of drugs. The FDA said Valisure's higher...

  • Oct 2- The U.S. Food and Drug Administration said on Wednesday it found "unacceptable levels" of a cancer-causing impurity in limited testing using low-heat method of samples of heartburn medicines such as Zantac containing the ingredient ranitidine. However, the agency said its testing method found much lower levels of the impurity, N-nitrosodimethylamine,...