The use of certain qualified health claims regarding the association between the consumption of high flavanol cocoa powder and a lower risk of cardiovascular disease is not anticipated to be objected by the US FDA. However, the US FDA determined that there is very little credible scientific evidence for the reduced risk, which will restrict […]
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The Kellogg Company petitioned the U.S. Food and Drug Administration (FDA) to allow vitamin D fortification in grain-based bars and to raise the maximum levels of fortification that can be used in cereal. As part of its Better Days Promise environmental, social, and governance (ESG) strategy, Kellogg Company is committed to addressing hidden hunger, or […]
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MediWound Ltd. has announced that NexoBrid (anacaulase-bcdb), a treatment for adults with deep partial- or full-thickness thermal burns, has been approved by the U.S. Food and Drug Administration (FDA) for the removal of eschar. MediWound’s chief executive officer, Ofren Gonen, said that the FDA’s approval of NexoBrid, an innovative non-surgical treatment for severe burn injuries, […]
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Roche reported that the U.S. Food and Drug Organization (FDA) has supported Actemra intravenous for the treatment of Coronavirus in hospitalized grown-up patients who are getting foundational corticosteroids and require supplemental oxygen, painless or obtrusive mechanical ventilation, or extracorporeal film oxygenation (ECMO). Actemra is the first monoclonal antibody for COVID-19 treatment that has been approved […]
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The US Food and Drug Administration (FDA) has approved the COVID-19 vaccine developed by Novavax for emergency use in teenagers between the ages of 12 to 17 years. Besides the emergency use authorisation, the COVID-19 vaccine will also be offered as a two-dose primary series for US teenagers. This authorization is considered to be the […]
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The US health agency approved Darolutamide, developed by Bayer, to treat patients with metastatic hormone-sensitive prostate cancer (HSPC). Darolutamide can be given alongside docetaxel plus androgen deprivation therapy (ADT). The efficacy of Darolutamide in the patients was demonstrated in the phase 2 trial. in particularly, use of Darolutamide despite placebo in combination with docetaxel plus […]
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The US Food and Drug Administration (FDA), said certain samples of sitagliptin, a compound in diabetes drugs Janumet and Januvia by Merck, were contaminated with a possible carcinogen. The US FDA said it will temporarily allow Merck to market and distribute drugs with sitagliptin, which contains a higher-than-normal acceptable amount of the impurity known as […]
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The Food and Drug Administration (FDA) of the United States said, it is going to allow the release of around 300,000 cans of the EleCare infant formula based on amino acid by the Abbott Laboratories. The formula had been previously produced at the Sturgis facility of the company based in Michigan, and the regulator said […]
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The Food and Drug Administration (FDA) of the United States has granted approval to a breakthrough device designation of Wysa, an artificial intelligence based platform, for the company’s digital mental health conversational agent based in artificial intelligence for the patients above 18 years along with a diagnosis of the chronic musculoskeletal pain along with depression […]
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The Food and Drug Administration (FDA) of the United States has given the approval to Camzyos of Bristol Myers Squibb for the purpose of treating the symptomatic obsutructive hypertrophic cardiomyopathy (obstructive HCM). The drug, which is formerly known as mavacamten, has been representing a potential and important addition to the cardiovascular stable, which is needing […]
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