HealthQuill Food and Drug Administration
The Food and Drug Administration has cleared GSK Plc’s drug for treating patients with inadequately controlled chronic obstructive pulmonary disease (COPD).
Drugs Medical Pharma

GSK Plc’s drug to treat COPD gets clearance from US drug regulator

HQ Team May 24, 2025: The Food and Drug Administration has cleared GSK Plc’s drug for treating patients with inadequately controlled chronic obstructive.

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The Food and Drug Administration has come out with new product-specific guidances for developing generic drugs and generating evidence to support abbreviated new drug application approvals.
Drugs Health Pharma

FDA draws up new product guidance for developing generic drugs

HQ Team May 21, 2025: The Food and Drug Administration has come out with new product-specific guidances for developing generic drugs and generating.

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The Food and Drug Administration has cleared the first at-home cervical cancer screening test in the US, according to a statement from Teal Health, its maker.
Health Medical Pharma

US approves first at-home cervical cancer screening from Teal Health

HQ Team May 12, 2025: The Food and Drug Administration has cleared the first at-home cervical cancer screening test in the US, according.

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Generic drugs made in India, which account for 93% of such medicines made from emerging countries, are linked to hospitalisation, disability and in a few cases death, compared to the US, according to a study by the Ohio State University.
Drugs Health Research

Generic Indian drugs have a 54% higher risk compared to US

HQ Team April 18, 2025: Generic drugs made in India, which account for 93% of such medicines made from emerging countries, are linked.

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The US Food and Drug Administration has rejected the biotechnology company Aldeyra Therapeutics Inc’s investigational drug for treating dry eyes, over concerns with the data from the trial.
Drugs Health Medical

Aldeyra Therapeutics’ dry eye treatment rejected by USFDA

HQ Team April 3, 2025: The US Food and Drug Administration has rejected the biotechnology company Aldeyra Therapeutics Inc’s investigational drug for treating.

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Mirum Pharmaceuticals Inc.’s oral cholesterol drug for treating a rare metabolic disease has been approved by the Food and Drug Administration.
Drugs Health Medical

US regulator clears Mirum’s oral drug for reducing cholesterol deposits

Mirum Pharmaceuticals Inc.’s oral cholesterol drug for treating a rare metabolic disease has been approved by the Food and Drug Administration.

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United Therapeutics Corporation, a public benefit corporation, got approval from US regulators to start a clinical trial for organ transplantation from genetically modified pigs to treat kidney disease.
Drugs Health Medical

US regulator approves pig organ transplant trial to treat kidney disease 

United Therapeutics Corporation, a public benefit corporation, got approval from US regulators to start a clinical trial for organ transplantation from genetically modified.

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Supernus Pharmaceuticals Inc’s injection for treating people with advanced Parkinson’s disease got a green light from the US regulator after two earlier rejections.
Drugs Health Medical

Supernus’ injection to treat advanced Parkinson’s gets US regulator’s nod

Supernus Pharmaceuticals Inc’s injection for treating people with advanced Parkinson’s disease got a green light from the US regulator after two earlier rejections.

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Franco-Italian EssilorLuxottica SA got approval from the Food and Drug Administration to market its over-the-counter audio glasses in the US for people with hearing loss.
Health Medical Pharma

EssilorLuxottica gets regulator nod for audio glasses in US, EU for hearing loss

Franco-Italian EssilorLuxottica SA got approval from the Food and Drug Administration to market its over-the-counter audio glasses in the US for people with.

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AstraZeneca’s drug for treating limited-stage small cell lung cancer got a recommendation for approval from an EU regulator panel, according to the British-Swedish drugmaker.
Uncategorized

EU panel gives a positive opinion for AstraZeneca’s cancer drug

AstraZeneca’s drug for treating limited-stage small cell lung cancer got a recommendation for approval from an EU regulator panel, according to the British-Swedish.

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