FDA

FDA Approves Eli Lilly's Alzheimer’s Drug Donanemab, Expanding US Treatment Options

FDA Approves Eli Lilly's Alzheimer’s Drug Donanemab, Expanding US Treatment Options

The FDA has approved Eli Lilly’s Alzheimer’s drug donanemab, branded as Kisunla, for early symptomatic adults, providing a new treatment option for nearly 7 million Americans affected by the disease.

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FDA Announces Recall of Glenmark, BluePoint Blood Pressure Capsules Over Cardiac Arrest Fear

FDA Announces Recall of Glenmark, BluePoint Blood Pressure Capsules Over Cardiac Arrest Fear

The US Food and Drug Administration (FDA) has announced the recall of 135 batches of potassium chloride extended-release capsules due to potential risks of cardiac arrest.

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Prophet Premium Blends Recalls Diamond Shruumz Edibles Due to Toxic Mushroom Chemical

Prophet Premium Blends Recalls Diamond Shruumz Edibles Due to Toxic Mushroom Chemical

Prophet Premium Blends is recalling all Diamond Shruumz edible products nationwide due to toxic levels of muscimol, a chemical found in certain mushrooms, which have caused illness in 39 people across 20 states.

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US Drugmakers, Medical Device Companies Urged by FDA to Improve Diversity in Clinical Trials

US Drugmakers, Medical Device Companies Urged by FDA to Improve Diversity in Clinical Trials

The US Food and Drug Administration (FDA) urged drugmakers and medical device manufacturers to improve racial and cultural diversity in clinical trials.

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FDA Warns Bimbo Bakeries to Not Label Products with Allergens When They Contain None

FDA Warns Bimbo Bakeries to Not Label Products with Allergens When They Contain None

The Food and Drug Administration said that they have warned the Mexican-American bakery Bimbo Bakeries to stop using labels saying that their products may have potentially dangerous allergens when they contain none.

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Snapchill Canned Coffee Products Recalled Over Deadly Botulism Toxin Fears

Snapchill Canned Coffee Products Recalled Over Deadly Botulism Toxin Fears

Coffee manufacturer Snapchill issued a countrywide product recall after federal regulators warned that its production process could produce a deadly toxin.

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FDA Approval of First Menthol E-Cigarettes for Sale in US Draws Parental Criticism

FDA Approval of First Menthol E-Cigarettes for Sale in US Draws Parental Criticism

The FDA has approved the first menthol e-cigarettes for sale in the US, prompting criticism from parent groups who claim the agency has "failed American families."

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FDA Approves Merck's Capvaxive Vaccine Designed to Prevent Pneumonia on Adults

FDA Approves Merck's Capvaxive Vaccine Designed to Prevent Pneumonia on Adults

The Food and Drug Administration approved Merck’s new vaccine, Capvaxive, which was designed to protect adults from a bacteria known as pneumococcus that could cause serious illnesses like pneumonia, but is yet to face the CDC’s scrutiny.

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GERMANY-HEALTH-BIONTECH-CANCER

FDA Pauses BioNTech's Chinese-Licensed Cancer Drug Trial Over Safety Issues

The FDA has paused BioNTech's breast and lung cancer trial involving licensed treatment from Chinese biotech MediLink Therapeutics Ltd., citing safety concerns.

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Neuroelectrics

Neuroelectrics Seeks FDA Approval for Non-Invasive Headcap for Epilepsy Treatment

Neuroelectrics seeks FDA approval for its noninvasive head cap that uses mild electrical currents to treat brain diseases, potentially transforming care for epilepsy, depression, and Alzheimer’s.

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FDA Took Over a Year to Act on Whistleblower Tip About Abbott Nutrition, New Audit Finds

FDA Took Over a Year to Act on Whistleblower Tip About Abbott Nutrition, New Audit Finds

An audit revealed that the FDA took over 15 months to act on a whistleblower complaint about conditions at an Abbott Nutrition factory.

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FDA, DOJ Unveil New Task Force to Combat Illegal Distribution and Sale of E-Cigarettes in the US

FDA, DOJ Unveil New Task Force to Combat Illegal Distribution and Sale of E-Cigarettes in the US

The US FDA and DOJ have announced the formation of a task force to combat the illegal distribution and sale of electronic cigarettes, or e-cigarettes.

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FDA Committee Endorses Eli Lilly’s Alzheinmer’s Drug

FDA Committee Endorses Eli Lilly’s Alzheinmer’s Drug

The Food and Drug Administration’s advisory committee endorsed Eli Lilly’s Alzheimer’s drug, donanemab, for approval to further slow the aggression of the specific type of dementia in patients despite criticisms regarding test patient deaths during clinical trials.

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US-TECHNOLOGY-SCIENCE-LIFESTYLE-COMPUTERS-ELECTRONICS

FDA Approves Abbott's Over-the-Counter Injectible Sensors That Can Monitor Glucose Levels in Real-Time

Abbott Laboratories announced that new FDA-cleared continuous glucose monitor sensors are available over-the-counter without a prescription.

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FDA Probes Diamond Shruumz Microdosing Chocolate Bars After 8 People Fall Sick

FDA Probes Diamond Shruumz Microdosing Chocolate Bars After 8 People Fall Sick

The FDA is examining Diamond Shruumz-brand microdosing chocolate bars after eight individuals experienced symptoms including vomiting, seizures, and central nervous system depression, prompting concerns over the product's safety.

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