Tag Archives: FDA

F.D.A. Approves Monthly Shots to Treat H.I.V.

F.D.A. Approves Monthly Shots to Treat H.I.V.

F.D.A. Approves Monthly Shots to Treat H.I.V. F.D.A. Approves Monthly Shots to Treat H.I.V. It’s what many people with H.I.V. have long awaited: monthly injections to keep the virus in check, instead of the three pills daily they now must take. The Food and Drug Administration on Thursday approved a combination of two monthly shots for treatment of H.I.V. in …

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Hahn Resigns as F.D.A. Commissioner; Woodcock Named Interim Chief

Hahn Resigns as F.D.A. Commissioner; Woodcock Named Interim Chief

Hahn Resigns as F.D.A. Commissioner; Woodcock Named Interim Chief Hahn Resigns as F.D.A. Commissioner; Woodcock Named Interim Chief Dr. Stephen M. Hahn, who became commissioner of the Food and Drug Administration just weeks before the coronavirus pandemic began, resigned on Wednesday as the administration of President Biden began. Dr. Janet Woodcock, the longtime head of the F.D.A.’s Center for Drug …

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Biden Picks Former F.D.A. Chief Kessler to Lead U.S. Vaccine Efforts

Biden Picks Former F.D.A. Chief Kessler to Lead U.S. Vaccine Efforts

Biden Picks Former F.D.A. Chief Kessler to Lead U.S. Vaccine Efforts Biden Picks Former F.D.A. Chief Kessler to Lead U.S. Vaccine Efforts President-elect Joseph R. Biden Jr. has chosen Dr. David Kessler to help lead Operation Warp Speed, the program to accelerate development of Covid-19 vaccines and treatments, according to transition officials. Dr. Kessler, a pediatrician and lawyer who headed …

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Rapid virus testing will ramp up inthe U.S., as F.D.A. approved three new at-home kits.

Rapid virus testing will ramp up inthe U.S., as F.D.A. approved three new at-home kits.

Rapid virus testing will ramp up inthe U.S., as F.D.A. approved three new at-home kits. Rapid virus testing will ramp up inthe U.S., as F.D.A. approved three new at-home kits. Amid surging coronavirus cases, the top U.S. testing official on Thursday announced another scale-up in the country’s diagnostic efforts, touting the importance of tests that can run from start to …

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F.D.A. Clears Moderna’s Covid Vaccine

F.D.A. Clears Moderna's Covid Vaccine

F.D.A. Clears Moderna’s Covid Vaccine F.D.A. Clears Moderna’s Covid Vaccine The Food and Drug Administration on Friday authorized the coronavirus vaccine made by Moderna for emergency use, allowing the shipment of millions more doses across the nation and intensifying the debate over who will be next in line to get inoculated. The move will make Moderna’s vaccine the second to …

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F.D.A. Panel Endorses Moderna’s Coronavirus Vaccine

F.D.A. Panel Endorses Moderna's Coronavirus Vaccine

F.D.A. Panel Endorses Moderna’s Coronavirus Vaccine F.D.A. Panel Endorses Moderna’s Coronavirus Vaccine Moderna is developing eight other vaccines that use mRNA. The company has tested them in animals and in 1,700 people, and has not had cases of anaphylaxis or other severe allergic reactions linked to the vaccine, Dr. Jacqueline Miller of Moderna said. One anaphylaxis case occurred two months …

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F.D.A. Clears Pfizer Vaccine, and Millions of Doses Will Be Shipped Right Away

F.D.A. Clears Pfizer Vaccine, and Millions of Doses Will Be Shipped Right Away

F.D.A. Clears Pfizer Vaccine, and Millions of Doses Will Be Shipped Right Away F.D.A. Clears Pfizer Vaccine, and Millions of Doses Will Be Shipped Right Away The Food and Drug Administration authorized Pfizer’s Covid-19 vaccine for emergency use on Friday, clearing the way for millions of highly vulnerable people to begin receiving the vaccine within days. The authorization is a …

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F.D.A. Panel Gives Green Light to Pfizer’s Covid Vaccine

F.D.A. Panel Gives Green Light to Pfizer's Covid Vaccine

F.D.A. Panel Gives Green Light to Pfizer’s Covid Vaccine F.D.A. Panel Gives Green Light to Pfizer’s Covid Vaccine Pfizer’s Covid-19 vaccine passed a critical milestone on Thursday when a panel of experts formally recommended that the Food and Drug Administration authorize the vaccine. The agency is likely to do so within days, giving health care workers and nursing home residents …

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Moderna Applies for Emergency F.D.A. Approval for Its Coronavirus Vaccine

Moderna Applies for Emergency F.D.A. Approval for Its Coronavirus Vaccine

Moderna Applies for Emergency F.D.A. Approval for Its Coronavirus Vaccine Moderna Applies for Emergency F.D.A. Approval for Its Coronavirus Vaccine The drugmaker Moderna said it would apply on Monday to the Food and Drug Administration to authorize its coronavirus vaccine for emergency use. The first injections may be given as early as Dec. 21 if the process goes smoothly and …

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F.D.A. Grants Emergency Authorization of Antibody Treatment Given to Trump

F.D.A. Grants Emergency Authorization of Antibody Treatment Given to Trump

F.D.A. Grants Emergency Authorization of Antibody Treatment Given to Trump F.D.A. Grants Emergency Authorization of Antibody Treatment Given to Trump The Food and Drug Administration has granted emergency authorization for the experimental antibody treatment given to President Trump shortly after he was diagnosed with Covid-19, giving doctors another option to treat Covid-19 patients as cases across the country continue to …

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