FDA spells out lower sodium goals for food industry – The Denver Post

NEW YORK — Food companies are coming under renewed pressure to use less salt after U.S. regulators spelled out long-awaited guidelines aimed at reducing sodium levels in dozens of foods including condiments, cereals, french fries and potato chips. The voluntary goals finalized Wednesday for 163 foods are intended to help lower the amount of salt people eat. A majority of […]

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U.S. FDA to review use of GBT's blood disorder therapy in children

(Reuters) – Global Blood Therapeutics Inc said on Tuesday the U.S. Food and Drug Administration had granted priority review for two applications related to its treatment for sickle cell disease in children. The company has filed for an accelerated approval of Oxbryta for the treatment of the disease in children aged four to 11 years and has also sought clearance […]

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FDA gives full approval to Pfizer COVID-19 vaccine

WASHINGTON (AP) — The U.S. gave full approval to Pfizer’s COVID-19 vaccine on Monday, a milestone that may help lift public confidence in the shots as the nation battles the most contagious coronavirus mutant yet. The vaccine made by Pfizer and its partner BioNTech now carries the strongest endorsement from the Food and Drug Administration, which has never before had […]

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FDA notifies Amazon over sale of certain harmful sexual enhancement products

(Reuters) -The U.S Food and Drug Administration (FDA) notified Amazon.com Inc over the sale of sexual enhancement and weight-loss products that had potentially harmful drug ingredients, in a letter addressed to the company’s new boss Andy Jassy.FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew KellyThe […]

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FDA Approves Semglee (insulin glargine-yfgn) as First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes

SILVER SPRING, Md., July 28, 2021 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product […]

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FDA Approves Vaxneuvance

FDA Approves Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Adults KENILWORTH, N.J.–(BUSINESS WIRE)– (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae […]

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FDA adds warning of rare reaction risk to Johnson & Johnson COVID vaccine

WASHINGTON — U.S. regulators on Monday added a new warning to Johnson & Johnson’s COVID-19 vaccine about links to a rare and potentially dangerous neurological reaction, but said it’s not entirely clear the shot caused the problem. The Food and Drug Administration announced the new warning, flagging reports of Guillain-Barre syndrome, an immune system disorder that can causes muscle weakness […]

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FDA Approves Rylaze

FDA Approves Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma DUBLIN, June 30, 2021 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) approval of Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic […]

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FDA extends Johnson & Johnson COVID-19 vaccine expiration dates

Pfizer now testing COVID-19 vaccine on children ages 5-11 Fox News medical contributor Dr. Janette Nesheiwat discusses Pfizer’s tests and the Moderna CEO announcing that the vaccine will be available to kids by this fall WASHINGTON – Johnson & Johnson said Thursday that U.S. regulators extended the expiration date on millions of doses of its COVID-19 vaccine by an extra […]

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FDA approves first drug to treat Alzheimer's patients since 2003

FDA approves first drug to treat Alzheimer’s patients since 2003 despite controversy over mixed clinical trial results On Monday, the FDA approved aducanumab, which was developed by Biogen Inc, to treat Alzheimer’s disease The drug removes amyloid beta proteins from the brain and could slow down patients’ cognitive decline  Aducanumab is not only the first drug of its kind  but also […]

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