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Tag Archives: FDA

Covid-19 vaccine shortfalls due to confusion over FDA requirements

Covid-19 vaccine shortfalls due to confusion over FDA requirements

Workers move boxes containing the Pfizer-BioNTech Covid-19 vaccine as they are prepared to be shipped at the Pfizer Global Supply Kalamazoo manufacturing plant in Kalamazoo, Michigan on December 13, 2020. Morry Gash | AFP | Getty Images Officials with Operation Warp Speed, the U.S. government program to distribute Covid-19 vaccines …

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Moderna Covid vaccine FDA approved for emergency use

U.S. plans to ship 6 million Moderna doses once FDA gives OK

The Food and Drug Administration has approved Moderna‘s coronavirus vaccine for emergency use. The vaccine — the second approved for use in the U.S. behind Pfizer and BioNTech‘s — bolsters the U.S. supply of doses. The potentially lifesaving shots are desperately needed to fend off the pandemic that has taken …

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FDA panel recommends emergency approval

FDA panel recommends emergency approval

An influential Food and Drug Administration advisory panel on Thursday overwhelmingly backed Moderna‘s coronavirus vaccine, a key step paving the way to distribute the second Covid-19 vaccine in the United States next week. The nonbinding decision, which was adopted 20 to 0 with one abstention, from the FDA’s Vaccines and …

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5 things to know before FDA panel votes on Moderna

5 things to know before FDA panel votes on Moderna

Medical syringes are seen with Moderna company logo displayed on a screen in the background in this illustration photo taken in Poland on October 12, 2020. Jakub Porzycki | NurPhoto | Getty Images A key Food and Drug Administration advisory panel is scheduled to vote Thursday on whether to recommend …

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FDA authorizes Abbott’s rapid $25 Covid test for at-home use

FDA authorizes Abbott's rapid $25 Covid test for at-home use

Abbott Laboratories’ BinaxNow kit Abbott Labs The Food and Drug Administration on Wednesday announced that it has authorized Abbott Labs‘ rapid Covid-19 test for at-home use, though doctors must prescribe the test for patients. The test, which is an antigen test that delivers results in about 15 minutes, had previously …

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Pfizer’s Covid vaccine approved by FDA for emergency use

Dr. Archana Chatterjee explains her FDA panel 'no' vote on Pfizer Covid vaccine

The Food and Drug Administration has approved Pfizer and BioNTech‘s coronavirus vaccine for emergency use, a monumental turning point in the once-in-a-century pandemic that has taken nearly 300,000 American lives in less than a year and wreaked havoc on the U.S. economy. FDA Chief Scientist Denise Hinton told Pfizer in …

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Why the Covid vaccine rollout will be ‘a Herculean operation’

Why the Covid vaccine rollout will be ‘a Herculean operation’

President-elect Joe Biden’s Covid advisory board member Dr. Atul Gawande told CNBC that the Covid-19 vaccine rollout “is a Herculean operation” with potential hitches along the way as Pfizer’s Covid vaccine just took a big step toward FDA approval for emergency use. “The biggest challenge is going to be both production …

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FDA panel recommends approval for emergency use

FDA panel recommends approval for emergency use

A key Food and Drug Administration advisory panel on Thursday recommended the approval of Pfizer and BioNTech’s coronavirus vaccine for emergency use in people over 16 years old, the last step before the FDA gives the final OK to broadly distribute the first doses throughout the United States. If the …

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6 things to know before FDA panel votes today

6 things to know before FDA panel votes today

A vial of the Pfizer/BioNTech COVID-19 vaccine. Liam McBurney | Reuters A Food and Drug Administration panel is scheduled to vote Thursday on whether to recommend the approval of Pfizer and BioNTech’s coronavirus vaccine for emergency use. The non-binding decision from the agency’s Vaccines and Related Biological Products Advisory Committee, …

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FDA may authorize Pfizer’s this week

FDA may authorize Pfizer's this week

Dr. Joseph Varon, left, and other medical staff member talk to a patient in the COVID-19 intensive care unit (ICU) at the United Memorial Medical Center on December 6, 2020 in Houston, Texas. Go Nakamura | Getty Images The Food and Drug Administration could authorize a coronavirus vaccine as early as the …

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Covid treatment used by Trump authorized by FDA

Covid treatment used by Trump authorized by FDA

View of Corporate and Research and Development Headquarters of Regeneron Pharmaceuticals on Old Saw Mill River Road in Tarrytown, New York. Lev Radin | LightRocket | Getty Images The Food and Drug Administration on Saturday granted an emergency use authorization for Regeneron‘s Covid-19 antibody treatment, the experimental therapy given to …

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Pfizer will apply for FDA emergency use authorization

Pfizer will apply for FDA emergency use authorization

Pfizer and BioNTech will apply Friday for an emergency use authorization from the Food and Drug Administration for their coronavirus vaccine. If Pfizer’s application is approved, the vaccine will likely be limited and rolled out in phases, with health-care workers, the elderly and people with underlying health conditions getting the …

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WHO tells doctors don’t use Gilead’s remdesivir, splitting with FDA

WHO tells doctors don't use Gilead's remdesivir, splitting with FDA

A lab technicians shows the coronavirus disease (COVID-19) treatment drug “Remdesivir”. Amr Abdallah Dalsh | Reuters A World Health Organization panel advised doctors Thursday against using Gilead Sciences‘ antiviral drug remdesivir as a treatment for patients hospitalized with Covid-19, saying there is currently “no evidence” that it improves survival or …

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WuXi Biologics CEO predicts approval for Covid-19 antibody treatment

WuXi Biologics CEO predicts approval for Covid-19 antibody treatment

Chris Chen, chief executive officer at China’s WuXi Biologics, expects approval for a Covid-19 antibody treatment either “late this year or early next year, ” he told CNBC. WuXi Biologics, which sells outsourced laboratory and manufacturing services to biotech companies, has signed several deals with clients to research antibodies for …

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Ex-Obama FDA chief trusts agency’s approval process

Ex-Obama FDA chief trusts agency's approval process

Dr. Margaret Hamburg, former Food and Drug Administration commissioner in the Obama administration, told CNBC on Wednesday that she trusts the regulatory agency will adhere to strict scientific principles as it evaluates coronavirus vaccines. “It’s an agency that is so committed to strong science, the integrity of the people who …

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FDA approves emergency use for first at-home Covid-19 test kit

FDA approves emergency use for first at-home Covid-19 test kit

Covid-19 nasal swab test administered on patient. Lisa Maree Williams | Getty Images News | Getty Images The U.S. Food and Drug Administration (FDA) has approved emergency use for the first Covid-19 test that can be conducted entirely at home. The agency cleared the single-use test, which provides results within …

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‘Covid cases in U.S. should peak in January’

Coronavirus ‘about to explode’ before therapeutics

Scott Gottlieb, former Commissioner of the FDA Adam Jeffery | CNBC The next two to three months will be difficult for Americans as the coronavirus sweeps the nation and the second surge of the virus picks up steam, says Dr. Scott Gottlieb, the former commissioner of the FDA and a …

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