FDA

Pfizer COVID-19 vaccine gets FDA panel recommendation for young kids

Pfizer COVID-19 vaccine gets FDA panel recommendation for young kids

The US is one step closer to the anticipated authorization of a COVID-19 vaccine for young kids ages five to 11 years. An independent panel of advisers has recommended the US Food and Drug Administration (FDA) authorize the use of Pfizer's COVID-19 vaccine in children who fall in this age group, bringing the US closer than ever to a vaccine option that covers the majority of the population.

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Hello Fresh and EveryPlate meal delivery services recall onions in kits

Hello Fresh and EveryPlate meal delivery services recall onions in kits

EveryPlate and Hello Fresh, two meal delivery services, have recalled the onions found in their meal kits sold during a specific time period due to potential contamination with Salmonella. The two recalls follow last week's big onion recall announcement, which was made in conjunction with an ongoing investigation into a multi-state Salmonella outbreak across the US.

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Walmart recalls aromatherapy spray over deadly bacteria contamination

Walmart recalls aromatherapy spray over deadly bacteria contamination

Walmart is recalling thousands of bottles of a Better Homes & Gardens aromatherapy spray over potential contamination with a deadly bacteria called Burkholderia pseudomallei. The recall follows four illnesses in the US earlier this year that resulted in two deaths, according to the US Centers for Disease Control, which found the bacteria in a bottle of the aromatherapy spray sourced from one of the patients' homes.

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Big onion recall hits US and Canada as salmonella outbreak probe continues

Big onion recall hits US and Canada as salmonella outbreak probe continues

The CDC, FDA, and other public health officials have been investigating a multi-state salmonella outbreak that has resulted in more than 600 known illnesses and 129 hospitalizations. Though the probe continues, an update has been shared with the public: the illnesses may be linked back to onions imported over the summer from Mexico, resulting in a voluntary recall.

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FDA authorizes two more COVID-19 boosters with mix-and-match strategy

FDA authorizes two more COVID-19 boosters with mix-and-match strategy

As expected, the US Food and Drug Administration (FDA) has granted authorizations for Johnson & Johnson and Moderna's COVID-19 booster shots. In addition, the FDA has also authorized the mix-and-match approach to booster shots, meaning someone who, for example, received the Moderna vaccination initially doesn't necessarily need to get the Moderna booster shot.

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Muscle relaxant pills recalled because the dose is higher than listed

Muscle relaxant pills recalled because the dose is higher than listed

A batch of muscle relaxant tablets has been recalled because the bottles may contain a higher dosage than listed on the label. The company notes in its recall advisory that taking too much of this drug may result in excessive depression of the central nervous system, potentially causing issues that can include fainting, falling, coma, seizures, and death.

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Cheaper hearing aids rule proposed by FDA for over-the-counter options

Cheaper hearing aids rule proposed by FDA for over-the-counter options

Hearing aids could become far more affordable in the US, with the FDA proposing a new category of over-the-counter models potentially far cheaper than current, prescription hearing aids. The new rule would upend current legislation that requires hearing aids be fitted by an audiologist, and only after a medical exam is completed.

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Johnson & Johnson COVID-19 vaccine booster gets FDA panel recommendation

Johnson & Johnson COVID-19 vaccine booster gets FDA panel recommendation

Only a day after recommending an emergency use authorization for Moderna's booster vaccine dose, the FDA panel of advisers is back with a similar recommendation for Johnson & Johnson's Janssen COVID-19 vaccine. The committee unanimously voted in favor of granting J&J an emergency use authorization, though the terms under which the booster would be offered differs from the EUA granted to Pfizer.

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Blood pressure and fluid retention drugs recalled over cancer concerns

Blood pressure and fluid retention drugs recalled over cancer concerns

The FDA has published a new recall advisory from Lupin Pharmaceuticals over two different drugs: Hydrochlorothiazide and Irbesartan. The company, which stopped marketing these particular drugs in January, says it is recalling the batches due to potentially higher than acceptable levels of an impurity called N-nitrosoirbesartan.

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FDA panel recommends Moderna booster shot EUA for certain people

FDA panel recommends Moderna booster shot EUA for certain people

A Food and Drug Administration advisory panel has unanimously recommended granting emergency use authorization for a third Moderna shot, though only some people would be eligible for the booster shot. The recommendation follows Moderna's second-quarter financial details shared in August, which included information on the COVID-19 vaccine's efficacy six months after the second dose, as well as the booster for its booster shots to help protect against SARS-CoV-2 variants.

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FDA authorizes its first nicotine vape, but only with tobacco flavors

FDA authorizes its first nicotine vape, but only with tobacco flavors

The US Food and Drug Administration has granted its first market authorization for a small batch of electronic cigarette (vape) products, the agency has announced. The approval underscores the agency's intentions to target 'appealing' vape products amid growing public criticism over non-tobacco flavors and youth vaping trends.

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Pfizer asks FDA for COVID-19 vaccine expansion to 5-11 year old kids

Pfizer asks FDA for COVID-19 vaccine expansion to 5-11 year old kids

Pfizer's COVID-19 vaccine could soon be authorized for children aged 5-11, with the pharma company applying to the US FDA for an extension of its current permissions. The expansion, if approved by the Food and Drug Administration, would make Pfizer's drug - branded Comirnaty - the first vaccination option for children aged under 12 years.

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