The FDA has paused BioNTech's breast and lung cancer trial involving licensed treatment from Chinese biotech MediLink Therapeutics Ltd., citing safety concerns.
Tags: FDA
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.
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.
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.
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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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.
An audit revealed that the FDA took over 15 months to act on a whistleblower complaint about conditions at an Abbott Nutrition factory.
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.
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.
Abbott Laboratories announced that new FDA-cleared continuous glucose monitor sensors are available over-the-counter without a prescription.
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.
GSK has announced that the FDA has expanded the approval of its respiratory syncytial virus (RSV) vaccine, Arexvy, to those aged 50 to 59.
The Food and Drug Administration issued a recall to over 800,000 cream cheese items from the Wisconsin-based Schreiber Foods after the company found that it might contain traces of salmonella in them.
FDA posted a recall notice confirming the mass recall of Fresh Start Produce Sales cucumbers, which could be contaminated with salmonella.
