Tag Archives: FDA

Cardiac arrest is one of the leading causes of death around the world, killing 7 million to 9 million people a year. With standard care, 1 out of 10 people survive cardiac arrest. Neurescue, founded by Dr. Habib Frost and headquartered in Copenhagen, Denmark, aims to bring that survival rate …

Medical staff member Christina Mathers attends to a patient, who is unconscious, as she holds the patient’s hand in the COVID-19 intensive care unit (ICU) at the United Memorial Medical Center on December 21, 2020 in Houston, Texas. Go Nakamura | Getty Images Sorrento Therapeutics is working on new antibody …

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 …

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 …

U.S. President Donald Trump delivers remarks at an Operation Warp Speed Vaccine Summit at the White House in Washington, U.S., December 8, 2020. Tom Brenner | Reuters The Food and Drug Administration on Friday pushed back on a tweet from President Donald Trump that suggested Moderna‘s coronavirus vaccine had won …

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 …

[The stream is slated to start at 9 a.m. ET. Please refresh the page if you do not see a player above at that time.] A Food and Drug Administration panel is meeting Thursday to vote on whether to recommend the approval of Moderna‘s coronavirus vaccine for emergency use. Before …

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 …

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 …

Joel Saget | AFP | Getty Images U.S. Food and Drug Administration staff recommends monitoring people who get Pfizer or Moderna’s Covid-19 vaccine shots for possible cases of Bell’s palsy, saying it’s not necessarily a side effect but worth watching out for after a handful of trial participants got the …

Tony Potts, a 69-year-old retiree living in Ormond Beach, receives his first injection as a participant in a Phase 3 COVID-19 vaccine clinical trial sponsored by Moderna at Accel Research Sites on August 4, 2020 in DeLand, Florida. Paul Hennessy | NurPhoto | Getty Images The staff of the Food …

This creative image taken in a studio in Paris on November 16, 2020, showing a syringe and a vaccine vial with the reproducted logo of a US biotech firm Moderna, illustrates the announcement of an experimental vaccine against Covid-19 from Moderna that would be nearly 95% effective, marking a second …

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 …

The Food and Drug Administration vaccine advisory panel signed off on Pfizer’s Covid vaccine with a 17 to 4 vote, with one abstention on Thursday night. Dr. Archana Chatterjee, dean of the Chicago Medical School, was one of the four “no” votes. Chatterjee explained her decision during a Friday evening …

U.S. President Donald Trump and Stephen Hahn, Director of the Food and Drug Administration participate in the daily coronavirus task force briefing at the White House on April 24, 2020 in Washington, DC. Drew Angerer | Getty Images White House chief of staff Mark Meadows told the head of the …

Dr. Archana Chatterjee, a member of the FDA advisory panel who voted against recommending Pfizer‘s Covid-19 vaccine for emergency use, told CNBC on Friday that her opposition was because she did not believe 16- and 17-year-olds should be included right now. In a “Squawk Box” interview, Chatterjee said she would …

A vial of the Pfizer/BioNTech COVID-19 vaccine is seen ahead of being administered at the Royal Victoria Hospital in Belfast, Northern Ireland December 8, 2020. Liam McBurney | Pool | Reuters The U.S. Food and Drug Administration is “rapidly” working toward clearing Pfizer’s Covid-19 vaccine for emergency use after a …

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 …

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 …

[The stream is slated to start at 9 a.m. ET. Please refresh the page if you do not see a player above at that time.] A Food and Drug Administration panel is meeting Thursday to vote on whether to recommend the approval of Pfizer and BioNTech‘s coronavirus vaccine for emergency …

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, …

The two allergic reactions reported by U.K. health-care workers vaccinated against Covid-19 will likely be scrutinized by the Food and Drug Administration as it decides whether to authorize Pfizer‘s vaccine in the U.S. — though the incident shouldn’t be surprising, medical experts said on Wednesday. The U.K’s Medicines and Healthcare …

The Food and Drug Administration said Tuesday data from Pfizer’s coronavirus vaccine trials was consistent with recommendations put forth by the agency for an emergency use authorization, adding the vaccine was highly effective and did not raise any specific safety concerns. In briefing documents published ahead of an advisory meeting …

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 …

FDA Commissioner Dr. Stephen M. Hahn speaks as US President Donald Trump listens during the daily briefing on the novel coronavirus, COVID-19, in the Brady Briefing Room of the White House in Washington, DC on April 21, 2020. Mandel Ngan | AFP | Getty Images White House Chief of Staff …

A medical worker wearing personal protective equipment (PPE) inserts a Covid-19 test tube into a box at a drive-thru testing site at the Alemany Farmers Market in San Francisco, California, U.S., on Thursday, Nov. 19, 2020. David Paul Morris | Bloomberg | Getty Images The FDA on Wednesday authorized one …

Alex Azar speaks at Operation Warp Speed press conference, November 24, 2020. Source: CNBC The U.S. federal government is conducting a practice run this week of its coronavirus vaccine distribution networks with some test shipments as the drugs await emergency approval from the U.S. Food and Drug Administration in “just …

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 …

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 …

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 …

Vice President Mike Pence listens to US Secretary of Health and Human Services Alex Azar speak during a White House Coronavirus Task Force press briefing in the James S. Brady Briefing Room of the White House on November 19, 2020. Brendan Smialowski | AFP | Getty Images Health and Human …

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 …

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 …

Pfizer and BioNTech said Wednesday that a final data analysis found their coronavirus vaccine was 95% effective in preventing Covid-19 and appeared to fend off severe disease. The vaccine, called BNT162b2, becomes highly effective against the virus 28 days after the first dose, and its effectiveness was consistent across all …

The Food and Drug Administration has asked a group of advisors to set aside three days in early December for potential meetings to discuss Covid-19 vaccines — a key step in the agency’s authorization process, according to a person familiar with the plans. The advisory group may be asked to …

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 …

Alex Azar, secretary of Health and Human Services (HHS), speaks during a news conference at the CDC Roybal Campus in Atlanta, Georgia, U.S., on Wednesday, Oct. 21, 2020. Elijah Nouvelage | Bloomberg | Getty Images The U.S. Food and Drug Administration will move “as quickly as possible” to clear Pfizer …

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 …