HealthQuill USFDA
Dutch medical device maker, Philips Respironics, agreed to conduct further tests on its faulty ventilators after the USFDA said it was “unsatisfied” with the status of a recall.
Health Medical Pharma

US drug regulator ‘unsatisfied’ by Philips’s progress on ventilator recall

HQ Team October 6, 2023: Dutch medical device maker, Philips Respironics, agreed to conduct further tests on its faulty ventilators after the USFDA.

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The FDA is planning a pilot program to accelerate the development of drugs and biological products for rare diseases by helping companies gather relevant data and conduct trials.
Drugs Health Pharma

FDA plans project to aid companies in making drugs for rare diseases 

HQ Team October 4, 2023: The FDA is planning a pilot program to accelerate the development of drugs and biological products for rare.

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The US Food and Drug Administration has cleared Novavax’s updated Covid-19 vaccine for emergency use in adolescents 12 years of age or above, the regulator announced.
Drugs Health Pharma

Novavax gets FDA nod for updated Covid-19 vaccine for 12 years and above

HQ Team October 4, 2023: The US Food and Drug Administration has cleared Novavax’s updated Covid-19 vaccine for emergency use in adolescents 12.

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The USFDA has issued civil money penalties to 22 retailers selling illegal e-cigarettes and sought up to a maximum of $19,192 fine for a single violation from each retailer.
Drugs Health Pharma

USFDA imposes maximum fine on 22 retailers for selling illegal e-cigarettes

HQ Team September 29, 2023: The USFDA has issued civil money penalties to 22 retailers selling illegal e-cigarettes and sought up to a.

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Merck’s Biological Licence Application for a pulmonary arterial hypertension drug has been accepted for a priority review by the FDA.
Drugs Health Pharma

Merck gets priority review nod from USFDA for hypertension drug 

HQ Team September 28, 2023: Merck’s Biological Licence Application for a pulmonary arterial hypertension drug has been accepted for a priority review by.

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Eisai Co., and Biogen Inc., announced that their drug to treat Alzheimer’s disease and cognitive impairment has been approved in Japan.
Drugs Health Pharma

Japan approves Eisai Co, Biogen Inc’s Leqembi for Alzheimer’s 

HQ Team September 25, 2023: Eisai Co., and Biogen Inc., announced that their drug to treat Alzheimer’s disease and cognitive impairment has been.

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The European Commission granted Pfizer Inc., a marketing authorisation for its once-daily oral capsule to treat hair loss or alopecia aerate.
Drugs Health Pharma

Pfizer’s oral capsule Litfulo to treat hair loss gets EU approval

HQ Team September 19, 2023: The European Commission granted Pfizer Inc., a marketing authorisation for its once-daily oral capsule to treat hair loss.

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The USFDA stated that Accord Healthcare Inc.’s generic tacrolimus oral capsules, meant to treat organ rejection, were no longer automatically substitutable at the pharmacy due to increased toxicity.
Drugs Health Pharma

FDA rules Accord’s tacrolimus oral drug not “substitutable” for US market

HQ Team September 19, 2023: The USFDA stated that Accord Healthcare Inc.’s generic tacrolimus oral capsules, meant to treat organ rejection, were no.

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The USFDA has approved GSK Plc’s oral therapy to treat anaemia in patients with myelofibrosis, a type of bone cancer.
Drugs Health Pharma

USFDA gives nod for GSK’s Ojjaara bone cancer therapy 

The USFDA has approved GSK Plc’s oral therapy to treat anaemia in patients with myelofibrosis, a type of bone cancer.

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The US national public agency has recommended a COVID-19 vaccination policy where updated shots are given starting from six-month-old infants — in variance with the policies of European counterparts.
Drugs Health Pharma

CDC, ECDC differ on vaccination program for fall-winter season

HQ Team September 13, 2023: The US national public agency has recommended a COVID-19 vaccination policy where updated shots are given starting from.

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