FDA - HealthQuill

The Endocrinologic and Metabolic Drugs Advisory Committee of the FDA refused approval for a once-weekly jab to control blood sugar levels in people with type 1 diabetes, with seven members voting for and four against.

FDA panel rejects Novo Nordisk’s weekly jab to treat type 1 diabetes

The Endocrinologic and Metabolic Drugs Advisory Committee of the FDA refused approval for a once-weekly jab to control blood sugar levels in people.

by HealthQuill
May 26, 2024
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The US Food and Drug Administration has cleared Amgen’s drug to treat adult patients in the extensive stages of small cell lung cancer (ES-SCLC) with disease progression on or after chemotherapy.

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USFDA gives nod to Amgen’s therapy for treating small cell lung cancer

HQ Team May 17, 2024: The US Food and Drug Administration has cleared Amgen’s drug to treat adult patients in the extensive stages.

by HealthQuill
May 17, 2024
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A young boy, treated for a rare genetic disease, died during a mid-stage clinical trial conducted by Pfizer, according to a statement posted by a non-profit group on its website quoting a company statement.

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Boy dies during Pfizer’s clinical trial probing rare genetic disease

HQ Team May 8, 2024: A young boy, treated for a rare genetic disease, died during a mid-stage clinical trial conducted by Pfizer,.

by HealthQuill
May 8, 2024
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Almost a year after rejecting approval for ImmunityBio’s combination therapy to treat a type of bladder cancer the USFDA has given the green light to the company’s Anktiva treatment.

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USFDA grants approval for ImmunityBio’s bladder cancer drug

HQ Team April 23, 2024: Almost a year after rejecting approval for ImmunityBio’s combination therapy to treat a type of bladder cancer the.

by HealthQuill
April 23, 2024
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A bacteria that causes infections, including pneumonia, bloodstream infections, and meningitis are being treated by doctors with less effective old generic antibiotics — even though the US regulator has cleared seven next-generation antibiotics to deal with the germs.

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US doctors still prescribe old generic antibiotics, cost main factor

HQ Team April 20, 2024: A bacteria that causes infections, including pneumonia, bloodstream infections, and meningitis are being treated by doctors with less.

by HealthQuill
April 20, 2024
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Anglo-Swedish drugmaker, AstraZeneca will acquire clinical-stage Fusion Pharmaceuticals for $2 billion in cash to get access to the latter’s radioconjugates to treat cancer.

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FDA’s accelerated approval of cancer drugs is hasty and doubtful, says new report

HQ Team April 10, 2024: A new study has found that cancer drugs that got accelerated approval under the US Federal Drug Approval.

by HealthQuill
April 10, 2024
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Amylyx Pharmaceuticals announced it has started a process with the USFDA and Health Canada to voluntarily discontinue the marketing authorisations for its amyotrophic lateral sclerosis (ALS) therapy after the drug failed in a last-stage trial.

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Amylyx Pharma pulls out ALS therapy drug from US, Canada

HQ Team April 4, 2024: Amylyx Pharmaceuticals announced it has started a process with the USFDA and Health Canada to voluntarily discontinue the.

by HealthQuill
April 4, 2024
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The USFDA approved Swiss-based Basilea Pharmaceutica International’s Zevtera injection for the treatment of staphylococcus aureus bloodstream infections and skin infections in adults and community-acquired bacterial pneumonia in patients three months to 18 years, and adults.

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Swiss-based Basilea Pharmaceutical’s antimicrobial drug gets FDA nod

HQ Team April 4, 2024: The USFDA approved Swiss-based Basilea Pharmaceutica International’s Zevtera injection for the treatment of staphylococcus aureus bloodstream infections and.