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The FDA has expanded the label of a medicine that has been around for decades to include possible benefits in treating children with autism, but specialists warn it is not a cure.
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The US FDA has urgently recalled two popular ice cream brands across multiple states due packaging mistakes and hidden allergens
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In June, the FDA found that a Blinkit-affiliated dark store in Pune operated by a partner firm was functioning without a mandatory food safety licence. In the case of Zepto, a facility in Dharavi found instances of non-compliance with food safety norms. Both companies had resumed operations after clearance from the authorities.
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Menthol cigarettes, which comprise a third of the industry's total U.S. market share, have also faced scrutiny for their disproportionate impact on the health of Black communities.
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'Raw milk can contain dangerous bacteria such as Mycobacterium tuberculosis, Salmonella, E. coli, Campylobacter, Staphylococcus aureus, Yersinia, Brucella, Coxiella and Listeria. H5N1 avian influenza ('bird flu') virus has been found in raw milk from cows infected with H5N1 influenza virus,' The Liver Doc wrote.
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Our specially curated package of the most interesting articles to help you stay at the top of your game.
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This warning letter summarises contraventions regarding methods or controls followed at the facility which do not conform to the prescribed cGMP regulations and contains directional guidance for necessary corrections
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Kilitch Healthcare India issued the recall on November 13 and the Food and Drug Administration published the notice on November 15. The recall is something of a formality, since the FDA had already alerted US stores last month to stop selling the over-the-counter drops.
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The Food and Drug Administration has reprimanded at least 28 companies this year, saying they failed to prove sufficient testing of ingredients used in over-the-counter drugs and consumer products for the toxins ethylene glycol (EG) and diethylene glycol (DEG), according to a Reuters analysis of agency import alerts and warning letters to manufacturers.
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This generic version, known as Bromfenac Ophthalmic Solution 0.09%, will be manufactured at Lupin's facility at Pithampur
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Police have seized a stock of food items, including different edible oils, worth Rs 4.82 lakh from a godown in Thane district of Maharashtra.
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On at least four occasions since 2019, Musk has predicted that his medical device company would begin human trials for a brain implant to treat severe conditions such as paralysis and blindness.
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Infectious disease specialists said the strain had not been previously detected in the United States, and that it was particularly difficult to treat with existing antibiotics.
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The approval granted by the US Food and Drug Administration (US FDA) is for the abbreviated new drug application for Brexpiprazole tablets of strengths 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, the company said in a regulatory filing.
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Over 25,200 boxes of Starbucks' chilled vanilla coffee, each containing 12 bottles, were voluntarily withdrawn by the distributor -- Pepsico Inc -- in the United States, according to the Food and Drug Administration.
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India has a much higher limit of lead in baby food, apart from several other categories of packaged food, and there is no indication of any revision in the norms in the near future
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During the all-day meeting, the 21-member committee discussed an array of weighty issues including the efficacy of existing vaccines, the composition of future vaccine strains and the need to match them to the circulating variants of SARS-CoV-2, the possibility of moving to an annual-shot model, the potential seasonality of the virus and much more.
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The agency is trying to simplify its COVID-19 vaccine policy as it considers whether to recommend Americans get an annual booster shot for the virus. But several members of the expert advisory group asked for more robust data on benefits of annual shots for younger, healthier people.
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The approval was based on data from the phase 3 ALPINE trial, a head-to-head comparison of BTK inhibitors. Patients were randomly assigned to zanubrutinib or ibrutinib. Ibrutinib is a first-generation BTK inhibitor and the current standard treatment.
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The US FDA’s EIR is received for the drug-device combination to be commercialised from the Stelis Pharma's flagship facility in Bengaluru, India
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Last week, the CDC and US FDA had said that Pfizer and BioNTech's updated (bivalent) COVID-19 vaccines could be linked to a type of brain (ischemic) stroke in people aged 65 and older
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Lupin Pharmaceutical got the United States' drug regulator's nod to market fesoterodine fumarate extended-release tablets
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The drug, Leqembi, is the first that's been convincingly shown to slow the decline in memory and thinking that defines Alzheimer's by targeting the disease's underlying biology.
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Hemgenix stands to be the costliest drug in the world, priced at $3.5 million per dose
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The FDA's (Foods) Joint Commissioner, S R Kekre, said the samples tested revealed that palmolein oil was mixed in products sold as sunflower and soyabean oils, rice bran oil was mixed in a product sold as mustard oil and vegetable oil was mixed in products claimed to be milk cream and ghee.
