"Premature" To Change Authorized Covid Vaccines Dosing, Schedules: US Drug Regulator
World News | Reuters | Tuesday January 5, 2021
The US Food and Drug Administration said on Monday that the idea of changing the authorized dosing or schedules of COVID-19 vaccines was premature and not supported by the available data.
US Drug Regulator Investigating 5 Allergic Reactions After Pfizer Shot
World News | Reuters | Saturday December 19, 2020
The US Food and Drug Administration is investigating around five allergic reactions that happened after people were administered Pfizer Inc and BioNTech SE's COVID-19 vaccine in the United States this week, a top FDA official said late on Friday.
US Drug Regulator Recommends Emergency Approval Of Moderna Vaccine
World News | Reuters | Friday December 18, 2020
The US Food and Drug Administration (FDA) will "rapidly" work towards granting emergency approval of Moderna Inc's COVID-19 vaccine candidate, FDA Commissioner Stephen Hahn said on Thursday.
US To Revise Covid Vaccine Guidance After Allergic Reactions
World News | Agence France-Presse | Friday December 18, 2020
The US Food and Drug Administration (FDA) said Thursday it was working with Pfizer to revise a fact sheet for recipients of the Pfizer-BioNTech Covid-19 vaccine after two people had allergic reactions.
US Authorises First Rapid At-Home Covid-19 Test
World News | Agence France-Presse | Wednesday December 16, 2020
The United States on Tuesday authorized its first rapid at-home test for Covid-19, which is available over-the-counter and produces a result in around 20 minutes.
US Drug Regulator Denies Allegations Of Political Pressure Over Pfizer Vaccine
World News | Agence France-Presse | Saturday December 12, 2020
The US Food and Drug Administration on Saturday defended itself from allegations of political pressure over the timing of its Pfizer-BioNTech Covid vaccine approval and provided new information on the risks to people with allergies.
Pfizer Covid Vaccine Gets US Experts' Nod For Emergency Use Approval
World News | Agence France-Presse | Friday December 11, 2020
An expert committee convened by the US Food and Drug Administration voted heavily in favor of recommending the Pfizer-BioNTech Covid-19 vaccine for emergency use approval on Thursday.
"Triumph": Pfizer Vaccine Results Published In Peer-Reviewed Journal
World News | Agence France-Presse | Thursday December 10, 2020
The full results of a clinical trial for the Pfizer-BioNTech Covid-19 vaccine were published in the New England Journal of Medicine on Thursday, a major milestone that came as a committee of the US Food and Drug Administration met to discuss its approval.
Pfizer Covid Vaccine Has "Favourable Safety Profile": US Regulator
World News | Agence France-Presse | Tuesday December 8, 2020
The US Food and Drug Administration (FDA) issued a briefing document Tuesday saying the Pfizer-BioNTech Covid-19 vaccine is safe and effective, raising expectations the regulator is poised to grant emergency approval.
Covid Vaccine Could Reach First Americans By Mid-December: Top Health Official
World News | Reuters | Monday November 23, 2020
US healthcare workers and others recommended for the nation's first COVID-19 inoculations could start getting shots within a day or two of regulatory consent next month, a top official of the government's vaccine development effort said on Sunday.
US Approves First COVID-19 Self-Testing Kit, Results Within 30 Minutes
World News | Reuters | Wednesday November 18, 2020
The U.S. Food and Drug Administration said on Tuesday it had approved the first COVID-19 self-testing kit for home use that provides results within 30 minutes.
Glenmark Pharma Gets Regulatory Nod For Tacrolimus Capsules; Stock Gains Nearly 2%
Business | Edited by Peter Noronha | Wednesday November 11, 2020
Glenmark Pharma received final approval from USFDA for Tacrolimus capsules, which are used as immunosuppressants to prevent human immune system from rejecting liver, kidney and heart transplants.
US Gives Full Approval To Antiviral Drug Remdesivir To Treat COVID-19
World News | Agence France-Presse | Friday October 23, 2020
The US Food and Drug Administration on Thursday granted full approval to the antiviral drug remdesivir as a treatment for patients hospitalized with Covid-19, after conditional authorization was given in May.
Trump Accuses US Agency Of Slowing Down Coronavirus Vaccine Trials
World News | Reuters | Sunday August 23, 2020
U.S. President Donald Trump on Saturday accused members of the "deep state" at the Food and Drug Administration, without providing evidence, of working to slow testing of COVID-19 vaccines until after the November presidential election.
Gilead Seeks US Approval For Drug That Shortens Covid Recovery Time
World News | Reuters | Tuesday August 11, 2020
Gilead Sciences Inc has filed an application with the U.S. Food and Drug Administration seeking full approval for remdesivir, its experimental COVID-19 drug currently used under emergency authorization, the drugmaker said on Monday.
"Premature" To Change Authorized Covid Vaccines Dosing, Schedules: US Drug Regulator
World News | Reuters | Tuesday January 5, 2021
The US Food and Drug Administration said on Monday that the idea of changing the authorized dosing or schedules of COVID-19 vaccines was premature and not supported by the available data.
US Drug Regulator Investigating 5 Allergic Reactions After Pfizer Shot
World News | Reuters | Saturday December 19, 2020
The US Food and Drug Administration is investigating around five allergic reactions that happened after people were administered Pfizer Inc and BioNTech SE's COVID-19 vaccine in the United States this week, a top FDA official said late on Friday.
US Drug Regulator Recommends Emergency Approval Of Moderna Vaccine
World News | Reuters | Friday December 18, 2020
The US Food and Drug Administration (FDA) will "rapidly" work towards granting emergency approval of Moderna Inc's COVID-19 vaccine candidate, FDA Commissioner Stephen Hahn said on Thursday.
US To Revise Covid Vaccine Guidance After Allergic Reactions
World News | Agence France-Presse | Friday December 18, 2020
The US Food and Drug Administration (FDA) said Thursday it was working with Pfizer to revise a fact sheet for recipients of the Pfizer-BioNTech Covid-19 vaccine after two people had allergic reactions.
US Authorises First Rapid At-Home Covid-19 Test
World News | Agence France-Presse | Wednesday December 16, 2020
The United States on Tuesday authorized its first rapid at-home test for Covid-19, which is available over-the-counter and produces a result in around 20 minutes.
US Drug Regulator Denies Allegations Of Political Pressure Over Pfizer Vaccine
World News | Agence France-Presse | Saturday December 12, 2020
The US Food and Drug Administration on Saturday defended itself from allegations of political pressure over the timing of its Pfizer-BioNTech Covid vaccine approval and provided new information on the risks to people with allergies.
Pfizer Covid Vaccine Gets US Experts' Nod For Emergency Use Approval
World News | Agence France-Presse | Friday December 11, 2020
An expert committee convened by the US Food and Drug Administration voted heavily in favor of recommending the Pfizer-BioNTech Covid-19 vaccine for emergency use approval on Thursday.
"Triumph": Pfizer Vaccine Results Published In Peer-Reviewed Journal
World News | Agence France-Presse | Thursday December 10, 2020
The full results of a clinical trial for the Pfizer-BioNTech Covid-19 vaccine were published in the New England Journal of Medicine on Thursday, a major milestone that came as a committee of the US Food and Drug Administration met to discuss its approval.
Pfizer Covid Vaccine Has "Favourable Safety Profile": US Regulator
World News | Agence France-Presse | Tuesday December 8, 2020
The US Food and Drug Administration (FDA) issued a briefing document Tuesday saying the Pfizer-BioNTech Covid-19 vaccine is safe and effective, raising expectations the regulator is poised to grant emergency approval.
Covid Vaccine Could Reach First Americans By Mid-December: Top Health Official
World News | Reuters | Monday November 23, 2020
US healthcare workers and others recommended for the nation's first COVID-19 inoculations could start getting shots within a day or two of regulatory consent next month, a top official of the government's vaccine development effort said on Sunday.
US Approves First COVID-19 Self-Testing Kit, Results Within 30 Minutes
World News | Reuters | Wednesday November 18, 2020
The U.S. Food and Drug Administration said on Tuesday it had approved the first COVID-19 self-testing kit for home use that provides results within 30 minutes.
Glenmark Pharma Gets Regulatory Nod For Tacrolimus Capsules; Stock Gains Nearly 2%
Business | Edited by Peter Noronha | Wednesday November 11, 2020
Glenmark Pharma received final approval from USFDA for Tacrolimus capsules, which are used as immunosuppressants to prevent human immune system from rejecting liver, kidney and heart transplants.
US Gives Full Approval To Antiviral Drug Remdesivir To Treat COVID-19
World News | Agence France-Presse | Friday October 23, 2020
The US Food and Drug Administration on Thursday granted full approval to the antiviral drug remdesivir as a treatment for patients hospitalized with Covid-19, after conditional authorization was given in May.
Trump Accuses US Agency Of Slowing Down Coronavirus Vaccine Trials
World News | Reuters | Sunday August 23, 2020
U.S. President Donald Trump on Saturday accused members of the "deep state" at the Food and Drug Administration, without providing evidence, of working to slow testing of COVID-19 vaccines until after the November presidential election.
Gilead Seeks US Approval For Drug That Shortens Covid Recovery Time
World News | Reuters | Tuesday August 11, 2020
Gilead Sciences Inc has filed an application with the U.S. Food and Drug Administration seeking full approval for remdesivir, its experimental COVID-19 drug currently used under emergency authorization, the drugmaker said on Monday.
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