HealthQuill USFDA
An advisory committee of the USFDA has given a “favourable benefit-risk profile” for Sanofi and AstraZeneca’s experimental drug nirsevimab, meant to treat lower respiratory tract disease in newborns, according to a statement from the Paris-based firm.
Drugs Health Pharma

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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The FDA cleared Opiant Pharmaceuticals’ nasal spray to treat opioid overdose in adult and paediatric patients under the regulator’s priority review designation.
Drugs Health Medical Pharma

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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The USFDA has warned healthcare providers and consumers from using SD Biosensor Inc. pilot COVID-19 at-home tests due to bacterial contamination.
Drugs Health Medical Pharma

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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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.
Drugs Health Medical Pharma

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.

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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.
Drugs Health Medical Pharma

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.

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The US Food and Drug Administration has cleared Biogen Inc’s drug, branded as Qalsody, to treat amyotrophic lateral sclerosis (ALS), an aggressive and rare form of the disease in adults.
Drugs Health Medical Pharma

Biogen’s sclerosis drug gets FDA’s fast approval clearance

HQ Team April 26, 2023: The US Food and Drug Administration has cleared Biogen Inc’s drug, branded as Qalsody, to treat amyotrophic lateral.

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SAB Biotherapeutics got a fast-track designation from the USFDA for its investigational drug to treat influenza in high-risk and immunocompromised patients.
Drugs Medical Pharma

SAB gets FDA fast track nod for experimental drug to treat influenza

HQ Team April 14, 2023: SAB Biotherapeutics got a fast-track designation from the USFDA for its investigational drug to treat influenza in high-risk.

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Fusion Pharmaceuticals, a Canada-based radiopharmaceuticals company, announced FDA clearance for its investigational new drug applications to treat solid tumors.
Drugs Health Pharma

Canada’s Fusion gets FDA nod for drug tests to treat solid tumors

HQ Team April 13, 2023: Fusion Pharmaceuticals, a Canada-based radiopharmaceuticals company, announced FDA clearance for its investigational new drug applications to treat solid.

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Merck KGaA announced the USFDA had put a hold on the initiation of new patients to test its relapsing multiple sclerosis drug after it caused liver injuries.
Drugs Health Pharma

FDA applies brakes on Merck’s multiple sclerosis drug tests

HQ Team April 13, 2023: Merck KGaA announced the USFDA had put a hold on the initiation of new patients to test its.

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The FDA has withdrawn Netherland-based Covis Pharma’s drug meant to cut preterm birth as it failed to prove its benefits in clinical trials.
Drugs Health Medical Pharma

FDA withdraws approval for Covis’ preterm birth prevention drug

HQ Team April 7, 2023: The FDA has withdrawn Netherland-based Covis Pharma’s drug meant to cut preterm birth as it failed to prove.

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