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2966 Articles Matching "fda"

Roche's Tecentriq wins fast FDA review in tough-to-treat breast cancer

Nov 14, 2018 , Reuters
Swiss drugmaker Roche said on Tuesday its Tecentriq medicine will get a speedy review by U.S. regulators in a tough-to-treat form of breast cancer, as it seeks to be the first company to have its immunotherapy win approval in this indication....
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Blu e-cigarette maker plans to restrict online sales amid FDA crackdown on teen use

Nov 14, 2018 , CNBC Health
Fontem Ventures, a unit of tobacco company Imperial Brands, says it will raise the minimum age requirements to buy nicotine pods on its website to 21 regardless of where consumers are shopping....
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Cipla gets FDA OK for generic Valcyte

Nov 14, 2018 , Drug Store News - Retail
The FDA has approved Cipla's generic Valcyte, which had a market value of about $79 million. Read More...
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U.S. physicians urge FDA to bolster labeling on high-sugar foods

Nov 14, 2018 , Reuters
The American Medical Association (AMA) is urging the U.S. Food and Drug Administration (FDA) to ramp up labeling of high-sugar foods, it said in a statement on Tuesday....
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FDA Will Ban Many Flavored E-Cigarettes

Nov 14, 2018 , MedicineNet
Title: FDA Will Ban Many Flavored E-CigarettesCategory: Health NewsCreated: 11/9/2018 12:00:00 AMLast Editorial Review: 11/12/2018 12:00:00...
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Janssen gets FDA green light for new Invokana indication

Nov 14, 2018 , Drug Store News - Retail
Janssen's oral diabetes treatment is the first oral diabetes treatment to have an indication to reduce the risk of heart attack, stroke or cardiovascular death, the company said. Read More...
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Lupin receives FDA blessing for generic Pulmicort

Nov 14, 2018 , Drug Store News - Retail
Lupin has received the FDA's nod for generic Pulmicort, which had a market value of about $474.5 million. Read More...
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As Dangerous Food Allergies Skyrocket In Kids, Scientists Wonder If Hypoallergenic Peanuts Could Be The Answer

Nov 14, 2018 , Kaiser Health News
“One kid in every classroom has some sort of food allergy,” said Dr. Scott Commins, an allergist and immunologist at the University of North Carolina at Chapel Hill. “You put it on that sort of scale, you realize that we’re dealing with a huge issue that doesn’t seem to be going away.” Meanwhile, the FDA is considering adding sesame to the list of possible allergens that labels have to...
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Amgen’s Kyprolis’ new dosing option gets FDA nod

Nov 14, 2018 , Drug Store News - Retail
Amgen's Kyprolis now offers patients with relapsed or refractory multiple myeloma the option of a more convenient dosing regime. Read More...
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Threat of a looming ban on menthol cigarettes weighs on tobacco stocks

Nov 13, 2018 , CNBC Health
FDA Commissioner Dr. Scott Gottlieb plans to announce this week the agency will move forward with a ban on menthol cigarettes, senior FDA officials told CNBC last...
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FDA touts record-breaking number of October generic approvals

Nov 13, 2018 , Drug Store News - Retail
The Food and Drug Administration approved 110 generic drugs and tentatively approved 18 generic drugs for a total of 128 approval actions throughout the month of October. Read More...
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Theravance Biopharma, Mylan get FDA approval for Yupelri

Nov 13, 2018 , Drug Store News - Retail
Yupelri is the first and only once-daily nebulized bronchodilator approved for the treatment of COPD, the companies said. Read More...
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FDA Says Primatene Mist Inhaler is Back for Asthmatics

Nov 11, 2018 , MedicineNet
Title: FDA Says Primatene Mist Inhaler is Back for AsthmaticsCategory: Health NewsCreated: 11/8/2018 12:00:00 AMLast Editorial Review: 11/9/2018 12:00:00...
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Data Points: Opioid prescription numbers are down, but still a problem

Nov 11, 2018 , Modern Healthcare Breaking News
The FDA on Nov. 2 approved a new super-potent opioid tablet for use in hospitals. While prescribing numbers for opioids have been declining for the past few years, prescription use of painkillers still present a major challenge for combating...
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FDA to Ban Most Flavored E-Cigarettes

Nov 11, 2018 , MedicineNet
Title: FDA to Ban Most Flavored E-CigarettesCategory: Health NewsCreated: 11/9/2018 12:00:00 AMLast Editorial Review: 11/9/2018 12:00:00...
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Listen: Teen Vaping Sparks FDA Crackdown

Nov 10, 2018 , Kaiser Health News
Federal regulators want to ban the sale of most flavored e-cigarettes at retail locations like gas stations and convenience...
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FDA to Ban Most Flavored E-Cigarettes

Nov 10, 2018 , WebMD
The agency will also mandate age age-verification measures for online sales to prevent minors from buying the flavor...
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New In Vitro Fertilization Technique Aims To Be Liquid Biopsy For Embryos, But Raises Concerns

Nov 10, 2018 , Forbes
“It would be nice if there were more FDA regulatory oversight in this area,” says a...
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Mylan and Theravance's COPD treatment gets FDA approval

Nov 10, 2018 , Reuters
Theravance Biopharma Inc and partner Mylan NV on Friday won U.S. regulatory approval for their treatment for a chronic lung condition that causes breathing-related problems....
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FDA approved clobazam oral film formulation

Nov 10, 2018 , Drug Store News - Retail
Sympazan is the first clobazam oral film formulation approved by the Food and Drug Administration, maker Aquestive Therapeutics said. Read More...
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