Category: U.S. FDA

Canada Sought Help From U.S. on Paxlovid Use, Vaccination Messaging

January 24, 2023
CanadaCCP VirusCOVID-19PaxlovidPublic Health Agency of CanadaPUBLIC HEALTH INFORMATIONTeresa TamU.S. FDAWorld
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Communication on COVID-19 between top public health officials in Canada and the U.S. has been limited, based on access to information records, but the few pieces of information released by the Canadian government show its chief public health officer leaning on her counterparts for advice. The Epoch Times filed an Access to Information (ATIP) request…

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Canada Sought Help From US on Paxlovid Use, Vaccination Messaging

January 24, 2023
CanadaCCP VirusCOVID-19PaxlovidPublic Health Agency of CanadaPUBLIC HEALTH INFORMATIONTeresa TamU.S. FDAWorld
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Communication on COVID-19 between top public health officials in Canada and the U.S. has been limited, based on access to information records, but the few pieces of information released by the Canadian government show its chief public health officer leaning on her counterparts for advice. The Epoch Times filed an Access to Information (ATIP) request…

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Roche Says FDA Grants Priority Review to Actemra for COVID-19

April 5, 2022
Business & EconomyCCP VirusCompaniesRocheU.S. FDAWorld
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ZURICH—Roche said on Monday the U.S. Food and Drug administration granted priority review to its Actemra/RoActemra for the treatment of COVID-19 in hospitalized adults. “If approved, Actemra/RoActemra would be the first U.S. FDA-approved immunomodulator for the treatment of COVID-19 in hospitalized patients,” Roche said in a statement, adding that more than 1 million people hospitalized…

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Australian Health Minister Confident Pfizer Will Be Approved for Children Aged 5 to 12

October 14, 2021
AustraliaCCP VirusGreg HuntInternationalPfizer/BioNTech vaccineTGAU.S. FDAVaccines & SafetyWorld
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The Pfizer COVID-19 vaccine could soon be given double green light approval for use in Australian children aged 5 to 12. Federal Health Minister Greg Hunt said the drug regulatory body, the Therapeutic Goods Administration (TGA) had given Pfizer provisional determination, allowing the company to speed up their application. “I think their application is likely…

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FDA Approves Expanded Use of Jazz Pharma’s Sleep Disorder Drug Xywav

August 12, 2021
biopharmaceuticalBusiness & EconomyCompaniesJazz Pharmaceuticalssleep disorder drugU.S. FDAUSUS News
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Jazz Pharmaceuticals PLC said on Thursday its sleep disorder drug Xywav received regulatory approval for the expanded use in patients suffering from excessive daytime sleepiness despite a good night’s sleep. Xywav is currently approved in the United States for the treatment of excessive daytime sleepiness and sudden loss of muscle tone in patients aged seven…

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