USFDA – Page 12 – HealthQuill

The USFDA has granted a standard approval for Eisai and Biogen's Alzheimer injection, Leqembi —the first treatment to secure the traditional approval, paving the way for wider insurance coverage of the drug.

USFDA grants green light to Eisai, Biogen’s Alzheimer’s drug Leqembi

HQ Team July 7, 2023: The USFDA has granted a standard approval for Eisai and Biogen’s Alzheimer injection, Leqembi —the first treatment to secure the.

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July 7, 2023
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Artificial sweetener, sucralose, is “genotoxic” as it breaks up the DNA and also causes damage to the gut lining or leaky gut, a study reveals.

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Artificial sweetener sucralose breaks up DNA, may cause ‘leaky gut’

HQ Team June 30, 2023: Artificial sweetener, sucralose, is “genotoxic” as it breaks up the DNA and causes damage to the gut lining.

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June 30, 2023
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Pfizer Inc. announced that USFDA has accepted its biologics license application for treating bleeding disorders in adults through gene therapy.

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FDA, EMA accept Pfizer’s BLP application for hemophilia therapy

HQ Team June 26, 2023: Pfizer Inc. announced that USFDA has accepted its biologics license application for treating bleeding disorders in adults through.

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June 27, 2023
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Indian pharmaceutical company, Lupin Limited, has introduced its thiamine injection in the US market and has got FDA’s ‘no action required’ classification for its domestic facility in the country’s south.

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India’s Lupin unveils thiamine injection in US, receives FDA’s NAR for Vizag unit

HQ Team June 20, 2023: Indian pharmaceutical company, Lupin Limited, has introduced its thiamine injection in the US market and has got FDA’s.

by HealthQuill
June 20, 2023
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FDA’s advisory panel backs Sanofi, AstraZeneca’s investigational drug for newborns

HQ Team June 9, 2023: An advisory committee of the USFDA has given a “favourable benefit-risk profile” for Sanofi and AstraZeneca’s experimental drug.

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June 9, 2023
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The FDA cleared Opiant Pharmaceuticals’ nasal spray to treat opioid overdose in adult and paediatric patients under the regulator’s priority review designation.

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Opiant’s nasal drug spray for opioid overdose gets FDA green light

HQ Team May 23, 2023: The FDA cleared Opiant Pharmaceuticals’ nasal spray to treat opioid overdose in adult and paediatric patients under the.

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May 23, 2023
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The USFDA has warned healthcare providers and consumers from using SD Biosensor Inc. pilot COVID-19 at-home tests due to bacterial contamination.

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FDA issues warning on SD Biosensor’s at-home COVID-19 test

HQ Team May 5, 2023: The USFDA has warned healthcare providers and consumers from using SD Biosensor Inc. pilot COVID-19 at-home tests due.

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May 5, 2023
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Del Maguey Co., majority-owned by Pernod Ricard, will voluntarily recall certain ceramic ware artisan cups used to drink an alcoholic beverage, mezcal, in the US due to excess levels of leachable lead.

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Del Maguey pulls out mezcal cups from US on leachable lead risk

HQ Team May 2, 2023: Del Maguey Co., majority-owned by Pernod Ricard, will voluntarily recall certain ceramic ware artisan cups used to drink.

by HealthQuill
May 2, 2023
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TruVision Health, a US-based healthcare company, will recall its dozen unapproved dietary products after an FDA inspection found them to be adulterated.

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TruVision to recall adulterated dietary products after FDA inspection

HQ Team May 2, 2023: TruVision Health, a US-based healthcare company, will recall its dozen unapproved dietary products after an FDA inspection found.