HealthQuill USFDA
The US drug regulator, FDA, did not have an organizational structure or assigned responsibilities to handle whistleblower complaints “efficiently and effectively” and took more than 15 months to address a February 2021 Abbott facility whistleblower complaint, according to a federal audit.
Drugs Health Pharma

US audit finds gaps in FDA’s procedures during infant formula crisis

The US drug regulator, FDA, did not have an organizational structure or assigned responsibilities to handle whistleblower complaints “efficiently and effectively” and took.

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Israel’s Teva Pharmaceuticals has sued US-based Corcept Therapeutics and Optime Care Inc., a specialty pharma, for monopolising the market for a drug used to treat a rare hormonal disorder.
Drugs Medical Pharma

Israel’s Teva Pharmaceuticals sue Corcept, Optime over drug monoploy

Israel’s Teva Pharmaceuticals has sued US-based Corcept Therapeutics and Optime Care Inc., a specialty pharma, for monopolising the market for a drug used to.

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The advisory committee of the US Food and Drug Administration has rejected a therapy using party drug MDMA, or ecstasy or molly to treat post-traumatic stress disorder.
Drugs Health Pharma

FDA advisers reject psychedelic party drug MDMA to treat PSTD in adults

The advisory committee of the US Food and Drug Administration has rejected a therapy using party drug MDMA, or ecstasy or molly to.

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The US drug regulator has approved Amen’s biosimilar, Bkemv, to treat rare blood disorders, according to a statement from the Food and Drug Administration.
Drugs Health Pharma

US drug regulator clears Amgen’s biosimilar to treat rare blood disorder

The US drug regulator has approved Amen’s biosimilar, Bkemv,  to treat rare blood disorders, according to a statement from the Food and Drug.

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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.
Drugs Health Pharma

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.

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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.
Drugs Health Pharma

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.

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The Food and Drug Administration has cleared X4 Pharmaceutical’s drug to treat a rare genetic disease that occurs in one in five million births.
Drugs Health Pharma

X4 Pharmaceutical’s drug to fight WHIM syndrome gets green light

HQ Team April 30, 2024: The Food and Drug Administration has cleared X4 Pharmaceutical’s drug to treat a rare genetic disease that occurs.

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The US health regulator has approved Pfizer’s drug to treat cervical cancer patients whose disease has progressed beyond the chemotherapy stage.
Drugs Health Pharma

Pfizer gets full US regulatory approval for cervical cancer drug

HQ Team April 30, 2024: The US health regulator has approved Pfizer’s drug to treat cervical cancer patients whose disease has progressed beyond.

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The US health regulator has approved a drug of Utility Therapeutics to treat adult women, 18 years or older, with “uncomplicated” urinary tract infections.
Drugs Health Pharma

Utility Therapeutics gets FDA nod for drug to fight urinary tract infections

HQ Team April 25, 2024: The US health regulator has approved a drug of Utility Therapeutics to treat adult women, 18 years or.

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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.
Drugs Health Pharma

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.

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