FDA

In September 2020, regulators asked for extra safety data on the new mRNA vaccines. The human cost of that request is far from clear.

Officials are warning drivers to stay off the slick roads in the Northeast as a powerful winter storm makes its way up from the South. Hundreds of accidents and massive power outages are being blamed on the storm.

The following is a transcript of an interview with Dr. Scott Gottlieb that aired Sunday, January 16, 2022, on "Face the Nation."

Dole has issued a recall for several packaged salad products, including those sold in Michigan, for potential listeria contamination.

Michigan health officials say the state has received its first shipment of newly authorized COVID-19 pill treatments, but it’ll only be prescribed in certain situations due to limited supply.

The state of Michigan received a limited supply of the new oral medications to treat COVID-19 after the emergency use authorization by the FDA.

The FDA said it's looking into rapid tests returning a false negative with Omicron compared to other variants.

The FDA said it's looking into rapid tests returning a false negative with Omicron compared to other variants.

Dr. Leonard Lee, a cardiac surgeon, explains every common tool he uses in his operating room.

Steve Baltin, Senior contributor for Forbes Magazine, breaks down the most anticipated tours due to take place in 2022 with comments on unexpected sold out bands and most valuable tickets to locate. (Jan. 4)

The latest variant has triggered record-breaking levels of COVID-19 infections across the country. Early into 2022, the virus is prompting disruptive staffing shortages in schools and air travel.

COVID cases are continuing to climb in Michigan as we begin the new year. It is essential to understand that our lab capacity limits daily case counts. Some of those numbers do not include people who only took a rapid antigen test at home, so the real numbers are likely higher.

The U.S. is expanding COVID-19 boosters as it confronts the omicron surge.

The Food and Drug Administration (FDA) plans to expand eligibility for Pfizer-BioNTech COVID-19 booster shots to children ages 12 to 15 in the coming days, NBC News reports.

Gottlieb also noted that places that have been hard hit early by Omicron are as soon as "two weeks away from peaking, but the rest of the country probably faces a hard month ahead of us."

Browse all of our full transcripts from 2022 of "Face the Nation" with Margaret Brennan.

Gottlieb also noted that places that have been hard hit early by Omicron are as soon as "two weeks away from peaking, but the rest of the country probably faces a hard month ahead of us."

The following is the full transcript of an interview with Dr. Scott Gottlieb on "Face the Nation" on January 2, 2022.

We might not be able to claim that 2021 was *the* wildest year in recent history (2020 will likely get that credit for quite some time), but it might be a close second.

This trim will decrease ABBV's weighting in the portfolio from about 3.53% to about 3.22%.

Recall alert: Check your diabetes medication

The guidelines say people who test positive for COVID-19, but have no symptoms, can leave isolation after five days without testing again.

A conversation with the nation’s top infectious disease doctor as the U.S. braces for another surge.

Drugmaker said it will cut wholesale cost of drug by 50% next month, which translates to $28,200 a year for patient.

The following is a transcript of an interview with Dr. Scott Gottlieb that aired Sunday, December 19, 2021, on "Face the Nation."

Seven vehicles on Interstate 35 crashed into each other near Faribault, Minnesota, after a semi-truck jackknifed on Dec. 17. Luckily, no injuries were reported.

They’re fine for snacking, but insect protein has its greatest potential as nutrient rich, climate-friendly livestock feed.

This is the story of the Great Michigan Pizza Funeral of 1973, also known as the Great Pizza Burial.

New data appears to show the incidence has increased since April, although the problem is still very rare. About nine deaths related to the issue. have also been confirmed.

The company announced that laboratory testing shows the drug retains its potency against the Omicron variant.

Pfizer said its experimental COVID pill reduces the risk of hospitalization or death by 89%.

America’s drug regulators have been without a permanent commissioner for almost a year. The problems are piling up.

"I pray that there will be another rescue. I pray that there will be another one or two," Kentucky Governor Andy Beshear said.

At least with adults, most Republicans see the benefit and have gotten vaccinated. With children, 6 in 10 Republicans view the vaccines as a bigger risk than the virus.

The bacteria was found during proactive, routine sampling in November. Because the mushrooms have a long shelf-life, MDARD said they could still be in consumer kitchens.

An anti-COVID pill made by drugmaker Merck has been under review by officials, and on Wednesday its fate rested in the hands of the FDA.

A new antiviral coronavirus treatment pill is close to being made available to patients. The pill works to reduce the progression of severe symptoms and hospitalizations.

The FDA is considering new pills that could treat people in early stages of COVID. Here's what to know about how they work, how effective they are and the impact they could make on the pandemic.

Flagship Food Group has issued a voluntary recall of TJ Farms brand frozen cauliflower due to a potential health risk.

Conagra Brands, Inc. has issued a voluntary recall of some of its Birds Eye Broccoli Tots after some consumers reported finding small rocks and metal fragments in the product.

The state reported this week that as of last Friday, more than 87,000 (10.5 percent) of Michigan children ages 5 to 11 have received their first dose of the

Amid a surge in cases, Michigan officials are now urging people to get their COVID-19 vaccine boosters, that are now approved for anyone over 18 years of a

The market for Puff Bar exploded in early 2020 after the FDA banned candy and fruit-flavored e-cigarettes, like Juul, citing their popularity among teens.

Many states have already moved to allow all adults to receive a COVID vaccine booster shot, ahead of the FDA and CDC's decision.

At least three states have formally moved to expand eligibility to all adults for a booster six months after receiving Pfizer or Moderna vaccination.

95% of Colorado's ICU beds are now full and nearly 40% of hospitals in the state are expected to experience staffing shortages within a week.

Califf, a longtime Duke University researcher who now works for Verily and Google Health, gets the nod for an agency stretched by the pandemic.

A booster would be a full 30 microgram dose given six months after the primary series of two shots given three weeks apart.

Pfizer already has FDA authorization for boosters for people ages 65 and older and those with high-risk conditions.

After a historic 20-month closure, the U.S. is reopening its borders.

After nearly two years, the US lifts its travel ban to UK visitors who have had both Covid vaccine doses.

The Packers quarterback

Pediatricians are urging parents to follow CDC guidelines and not lie about their children's age to get them vaccinated against COVID ahead of time.

But are they a good idea?

The agency says it wants to further study the risk of myocarditis, or the inflammation of the heart muscle, in children.

Police and witnesses in Japan say a man brandishing a knife on a Tokyo commuter train car stabbed several passengers before setting a fire, sending people scrambling to escape. The Tokyo Fire Department said 17 passengers were injured. (Oct. 31)

The following is a transcript of an interview with Claire Boogaard, Medical Director of the COVID-19 Vaccine Program, Children's National Hospital on Sunday, October 31, 2021.

The CDC is expected to provide its recommendation Tuesday.

The CDC is expected to provide its recommendation Tuesday.

The CDC is expected to provide its recommendation Tuesday.

Here's what's coming up on Local 4 News at 5.

University of Michigan virologist played a crucial role on the FDA’s COVID vaccine advisory panel when it came to the recommended authorization of COVID boosters, and vaccines for children.

Here is insight from this week’s FDA advisory panel meeting. The answer was somewhat technical.

The fourth "booster" dose is recommended for six months after the third "additional" dose for people with organ transplants, cancer or other conditions.

Parents across the country have mixed thoughts about kids getting vaccines, with some worrying about school safety.

COVID-19 vaccines for kids could arrive as early as next week. To help you prepare, we answer five practical questions.

As Pfizer’s COVID-19 vaccine for kids 5-11 years old nears final approval, health departments in Metro Detroit prepare to receive and administer shots.

A Food and Drug Administration (FDA) committee will be Tuesday to vote on whether to authorize Pfizer's COVID-19 vaccine for kids ages 5-11.

How soon could kids ages 5-11 get a COVID vaccine? Possibly by November, but the FDA and CDC must sign off on it.

How soon could kids ages 5-11 get a COVID vaccine? Possibly by November, but the FDA and CDC must sign off on it.

Federal regulators are expected to authorize the mixing and matching of COVID-19 booster shots this week.

The Food and Drug Administration is expected to announce this week people will be able to receive a COVID-19 vaccine booster shot with a vaccine from a different manufacturer than their original doses, according to reports in the New York Times, Washington Post and Wall Street Journal.

The outside panel of experts voted unanimously in favor of offering booster doses of the Johnson & Johnson vaccine at least two months after the first dose.

The outside panel of experts voted unanimously in favor of offering Moderna boosters to specific groups of people, at least six months after their second dose.

The U.S. Food and Drug Administration will ask its outside experts to review Merck's pill to treat COVID-19 at a meeting in late November.

The Food and Drug Administration’s (FDA) vaccine advisory panel is set to meet Thursday and Friday, Oct. 14-15, over Moderna and Johnson & Johnson booster shots.

The Food and Drug Administration is taking new steps to try to lower the amount of salt Americans take in on a daily bases.

The Food and Drug Administration is wrestling with how to decide on booster doses of the single-shot Johnson & Johnson COVID-19 vaccine.

The Food and Drug Administration’s vaccine advisory panel is set to meet Thursday and Friday, Oct. 14-15, and we are getting our first look at the data the panel will be using to make its recommendation on booster shots for Moderna and Johnson & Johnson.

Drugmaker Merck asked U.S. regulators Monday to authorize its pill for treating COVID-19 in what would add an entirely new and easy-to-use weapon to the world’s arsenal against the pandemic.

It’s a move that has been highly anticipated by pediatricians and many parents as coronavirus cases have risen in that age group.

Pfizer and BioNTech have officially submitted a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization of their COVID-19 vaccine for children aged 5 to 11.

Johnson and Johnson is formally asking the FDA to authorize a booster for its COVID-19 vaccine.

The FDA issued a warning Tuesday the potential for false positive results with certain lots of the Ellume COVID-19 Home Test due to a recently identified manufacturing issue.

Johnson & Johnson has asked U.S. regulators to allow booster shots of its COVID-19 vaccine as the U.S. government moves toward shoring up protection in more vaccinated Americans.

Since the coronavirus pandemic began, Dr. Frank McGeorge has been keeping viewers up-to-date and informed on all fronts. He’s been answering your questions about the vaccine, the vaccination process and more.

Here's what's coming up on Local 4 News at 5.

Pfizer has released information about the efficacy of vaccines for children ages five to eleven.

Here’s what’s coming up on Local 4 News at 4:

Health experts are split over whether COVID vaccine booster shots are needed and there will be a pivotal vote on Friday (Sept. 17).

The Food and Drug Administration released the following statement Friday, Sept. 10, 2021 as COVID-19 makers are racing to submit clinical data seeking regulatory approval for vaccines in children younger than 12.

Pfizer-BioNTech soon will be asking approval for use of its COVID-19 vaccine in children aged 5 and up, The New York Times reports.

The only approved treatments for COVID are the antiviral drug Remdesivir and monoclonal antibodies, but the best protection against the virus is -- and always has been -- getting vaccinated.

The CDC’s vaccine advisory panel held a public meeting on Monday and discussed the recent full FDA approval of Comirnaty, Pfizer’s COVID vaccine.

City employees in Ann Arbor are now required to be vaccinated against COVID-19 by October 8.

Booster shots will likely be recommended for people who received the Johnson & Johnson COVID-19 vaccine.

Many people still have not received the COVID-19 vaccine.

The FDA has given its full approval to a COVID-19 vaccine.

Some Metro Detroit communities will begin administering COVID vaccine booster shots to immunocompromised residents starting Monday.

A CDC advisory group voted unanimously to allow immunocompromised people to get a third dose of a COVID-19 vaccine.