HealthQuill USFDA
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.
Drugs Health Pharma

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.

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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. 
Drugs Health Pharma

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.

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US-based Varda Space Industries’ spacecraft in orbit crystallised a metastable form of a drug for HIV/AIDS — furthering the feasibility of processing pharmaceuticals in microgravity.
Drugs Health Pharma

US-based Varda Space crystallises HIV drug in microgravity

 HQ Team March 31, 2024: US-based Varda Space Industries’ spacecraft in orbit crystallised a metastable form of a drug for HIV/AIDS — furthering.

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The US regulator, the Food and Drug Administration, has approved Winrevair therapy of Merck & Co., Inc., to treat pulmonary arterial hypertension.
Drugs Health Pharma

US regulator clears Merck’s lung therapy after ‘significant’ results

 HQ Team March 27, 2024: The US regulator, the Food and Drug Administration, has approved Winrevair therapy of Merck & Co., Inc., to.

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The US regulator, the Food and Drug Administration plans to ban electrical stimulation devices due to “unreasonable and substantial risk” of illness or injury.
Drugs Medical Pharma

FDA attempts a second time to ban electrical stimulation devices

HQ Team March 26, 2024: The US regulator, the Food and Drug Administration plans to ban electrical stimulation devices due to “unreasonable and.

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The US Food and Drug Administration has cleared Orchard Therapeutics’s gene therapy to treat a disease affecting the brain and nervous system in children — the regulator’s first ever for the disorder.
Drugs Health Pharma

FDA green lights first-ever therapy for rare genetic disease in kids

HQ Team March 19, 2023: The US Food and Drug Administration has cleared Orchard Therapeutics’s gene therapy to treat a disease affecting the.

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Pfizer Inc., announced that a late-stage study on its Adcetris drug, for treating the most common lymphoma, yielded positive results and improved overall survival rates.
Drugs Health Pharma

Pfizer says trials on lymphoma drug ‘positive,’ extends life of patients 

HQ Team March 12, 2024: Pfizer Inc., announced that a late-stage study on its Adcetris drug, for treating the most common lymphoma, yielded.

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The FDA has issued revised draft guidance for early treatment of Alzheimer’s disease with drugmakers told to focus on medicines that are likely to predict a clinical benefit.
Drugs Health Pharma

FDA issues revised drug guidelines for early Alzheimer’s disease

HQ Team March 12, 2024: The FDA has issued revised draft guidance for early treatment of Alzheimer’s disease with drugmakers told to focus.

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Bayer AG, a German multinational pharmaceutical and biotechnology company, has bought the marketing rights in Europe for a heart drug for $310 million to expand its cardiology portfolio.
Drugs Health Pharma

Bayer acquires marketing rights for heart drug in Europe for $310 million

HQ Team March 4, 2024: Bayer AG, a German multinational pharmaceutical and biotechnology company, has bought the marketing rights in Europe for a.

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Johnson & Johnson announced that USFDA had approved a bi-weekly dose of its blood cancer therapy Tecvayli.
Drugs Health Pharma

Johnson & Johnson’s blood cancer medicine cleared for bi-weekly use

HQ Team February 21, 2024: Johnson & Johnson announced that USFDA had approved a bi-weekly dose of its blood cancer therapy Tecvayli. The regulatory.

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