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29 Mar
FDA Approves First Over-the-Counter Nasal Spray for Opioid Overdoses

FDA Approves First Over-the-Counter Nasal Spray for Opioid Overdoses

The U.S. Food and Drug Administration on Wednesday approved the over-the-counter use of a nasal spray that can reverse an opioid overdose.

Research has shown that wider availability of naloxone (Narcan) could save lives as the opioid epidemic rages on in this country.

24 Mar
Parts of Intestinal Scope Devices Can Break Off Inside Patients

Parts of Intestinal Scope Devices Can Break Off Inside Patients

A medical device used to diagnose and treat pancreatic and bile duct disease is getting attention from the U.S. Food and Drug Administration after pieces have fallen off and remained in patients’ bodies.

Previously, the FDA had expressed

22 Mar
Death Count Climbs in Outbreak Linked to Recalled Eyedrops

Death Count Climbs in Outbreak Linked to Recalled Eyedrops

WEDNESDAY, March 22, 2023 (HealthDay News) – A drug-resistant bacteria linked to recalled eye drops has now killed three people.

The U.S. Centers for Disease Control and Prevention r...

20 Mar
Gerber Baby Formula Recalled Due to Bacteria Concerns

Gerber Baby Formula Recalled Due to Bacteria Concerns

Perrigo Co., which makes Gerber Good Start SootheProTM Powdered Infant Formula, has recalled the product over concerns about contamination with a potentially dangerous bacteria.

Cronobacter sakazakii was possibly present between Jan. 2 and Jan. 18 at the compan...

17 Mar
FDA Advisors Back Full Approval of Paxlovid

FDA Advisors Back Full Approval of Paxlovid

Paxlovid, a medication that has helped millions of high-risk COVID patients avoid hospitalization and death since late 2021, moved one step closer to getting full approval from the U.S. Food and Drug Administration on Thursday.

An FDA advisory panel voted 16-1 that the P...

13 Mar
New Nasal Spray for Migraines Approved by FDA

New Nasal Spray for Migraines Approved by FDA

MONDAY, March 13, 2023 (HealthDay News) – Migraine sufferers will soon have a new treatment option that works more quickly and may be safer for people at risk of heart attack or stroke.

The U.S. Food and Drug Administration has approved Pfizer Inc.’s zavegepant (Zav...

09 Mar
Mammogram Centers Must Notify Patients of Breast Density, FDA Says

Mammogram Centers Must Notify Patients of Breast Density, FDA Says

New U.S. federal regulations will require mammography facilities to tell women if they have dense breasts, a description of how the tissue looks on the X-ray.

It can be more difficult to detect cancer in dense breast tissue on a mammogram. Having dense breasts is also a ...

08 Mar
Preterm Birth Drug Pulled From Market Over Lack of Effectiveness

Preterm Birth Drug Pulled From Market Over Lack of Effectiveness

Pregnant women will no longer have any drug to prevent preterm birth after the maker of the only available treatment announced Tuesday that it will withdraw its product, Makena, from the market.

Covis Pharma Group's decision follows a U.S. Food and Drug Administration ad...

07 Mar
Two More Brands of Eyedrops Recalled Over Infection Risks

Two More Brands of Eyedrops Recalled Over Infection Risks

U.S. Federal health officials have issued recall notices for two more brands of eyedrops.

In the latest round of recalls, the U.S. Food and Drug Administration posted notices after the companies voluntarily pulled several lots of their eyedrops from the market.

The...

06 Mar
FDA Panel to Again Weigh Merit of Decongestant That Many Call Useless

FDA Panel to Again Weigh Merit of Decongestant That Many Call Useless

Consumers have been using a common over-the-counter oral decongestant known as phenylephrine for years, but that may not continue much longer.

The U.S. Food and Drug Administration has asked a panel of its advisors to reassess the drug’s effectiveness. The medication...

02 Mar
FDA Panel Backs Second RSV Vaccine for Older Americans

FDA Panel Backs Second RSV Vaccine for Older Americans

Following hours of discussion over safety concerns, a U.S. Food and Drug Administration advisory panel on Wednesday recommended approval of a second RSV vaccine, this one made by GlaxoSmithKline, for use in Americans ages 60 and older.

The panel's recommendation was base...

01 Mar
Bed Rails Can Help and Harm: FDA Gives Guidance

Bed Rails Can Help and Harm: FDA Gives Guidance

While adult bed rails are marketed with safety in mind, they need to be used with caution, the U.S. Food and Drug Administration advises.

"Many death and injury reports related to entrapment and falls for adult portable bed rail products and hospital bed rails have been ...

01 Mar
FDA Panel Backs Pfizer's RSV Vaccine for Older Americans

FDA Panel Backs Pfizer's RSV Vaccine for Older Americans

In a tight vote, U.S. Food and Drug Administration advisors on Tuesday recommended the approval of an RSV vaccine that could be used in Americans ages 60 and up.

The vaccine, known as RENOIR, was developed by pharmaceutical giant Pfizer Inc. The same panel of advisors w...

28 Feb
FDA Takes Action Against Animal Tranquilizer Tied to Fatal ODs

FDA Takes Action Against Animal Tranquilizer Tied to Fatal ODs

The U.S. Food and Drug Administration said Tuesday that it has taken action to restrict imports of the veterinary tranquilizer xylazine to prevent illicit use of the drug.

While veterinarians use products containing xylazine to sedate large animals such as horses and dee...

24 Feb
After Criticism, FDA Pledges to Revamp Its Tobacco Division

After Criticism, FDA Pledges to Revamp Its Tobacco Division

The U.S. Food and Drug Administration’s heavily criticized tobacco program promised changes on Friday, including a five-year strategic plan to better outline priorities.

"As we enter this era of declining use of combustible tobacco and continued innovation in the e-ci...

23 Feb
Almond, Soy Drinks Can Be Called Milk, FDA Proposes

Almond, Soy Drinks Can Be Called Milk, FDA Proposes

THURSDAY, Feb. 23, 2023 (HealthDay News) – Plant-based beverages that use oats, soy, almonds, cashews and other products instead of dairy can continue to call themselves milk.

The U.S. Food and Drug Administration

16 Feb
FDA Panel Says Opioid Overdose Antidote Safe to Sell Over-the-Counter

FDA Panel Says Opioid Overdose Antidote Safe to Sell Over-the-Counter

A nasal spray that can reverse an opioid overdose should be sold over-the-counter, two expert panels to the U.S. Food and Drug Administration recommended Wednesday.

Research has shown that wider availability of naloxone -- brand named Narcan -- could save lives as the o...

15 Feb
FDA Panel Considers Making Opioid Antidote Drug Available Without Prescription

FDA Panel Considers Making Opioid Antidote Drug Available Without Prescription

A nasal spray that can reverse an opioid overdose may become available for easier over-the-counter purchase.

U.S. Food and Drug Administration advisers are meeting Wednesday to discuss making generic naloxone hydrochloride available without requiring interaction with a p...

09 Feb
Could a Vibrating Pill Ease Chronic Constipation?

Could a Vibrating Pill Ease Chronic Constipation?

A new treatment for chronic constipation may bring relief without having to use drugs.

It’s a vibrating pill called Vibrant that stimulates the colon as it passes through the body.

Although the pill was

31 Jan
After Baby Formula Scandal, FDA Announces New Unit Focused on Food Safety

After Baby Formula Scandal, FDA Announces New Unit Focused on Food Safety

Stung by recent food safety scandals -- most notably last year's infant formula shortage, the U.S. Food and Drug Administration announced Tuesday that it is creating a new unit devoted to food safety.

The newly dubbed Human Foods Program will wield wide-ranging powers.<...

27 Jan
FDA Could Ease Blood Donation Rules for Gay Men

FDA Could Ease Blood Donation Rules for Gay Men

Longstanding restrictions on blood donations from gay or bisexual men could soon shift towards a more nuanced policy, where such men are asked about sexual partners and practices instead, the U.S. Food and Drug Administration announced Friday.

Specifically, gay men who a...

27 Jan
FDA Says No to Regulating CBD Products as Supplements

FDA Says No to Regulating CBD Products as Supplements

The U.S. Food and Drug Administration said Thursday it can't regulate CBD supplements because there isn't enough evidence on their safety. The agency also called on Congress to create new rules for what has become a burgeoning industry.

"The use of CBD raises various saf...

27 Jan
Updated Booster Shots, Not Original COVID Vaccines, Should Be Standard: FDA Panel

Updated Booster Shots, Not Original COVID Vaccines, Should Be Standard: FDA Panel

The U.S. Food and Drug Administration's vaccine advisory panel on Thursday voted unanimously to recommend that the agency phase out original versions of COVID vaccines for use in the unvaccinated, in favor of updated bivalent booster shots.

Committee members also weighed...

26 Jan
Top FDA Official Involved in Baby Formula Debacle Resigns

Top FDA Official Involved in Baby Formula Debacle Resigns

A U.S. Food and Drug Administration official who has led the agency’s food policy efforts since 2018 announced his resignation on Wednesday.

Frank Yiannas was also among the top ...

24 Jan
FDA Wants to Lower Lead Levels in Baby Food

FDA Wants to Lower Lead Levels in Baby Food

The U.S. Food and Drug Administration has proposed stricter limits on levels of lead in infant food products.

The agency announced draft guidance for manufacturers that would lower allowable lead levels in processed foods meant for infants and children 2 years and younge...

23 Jan
U.S. Proposes to Make COVID Shot Annual, Much Like Flu Shot

U.S. Proposes to Make COVID Shot Annual, Much Like Flu Shot

The U.S. Food and Drug Administration on Monday asked its vaccine advisory panel to weigh a proposal to turn COVID vaccines into an annual shot for most Americans.

The committee will weigh the proposal at its Jan. 26 meeting.

Such a move would simplify future vacci...

20 Jan
New USDA Rules Ramp Up Oversight of Organic Food

New USDA Rules Ramp Up Oversight of Organic Food

FRIDAY, Jan. 20, 2023 (HealthDay News) – Organic food will soon have to comply with stricter labeling rules under new requirements announced Thursday by the U.S. Department of Agriculture (USDA).

In what the Organic Trade Organization (OTA) called the biggest change si...

12 Jan
FDA Approves New 2-Drug Combo Medicine for Asthma

FDA Approves New 2-Drug Combo Medicine for Asthma

Adults with asthma now have a new rescue medication to turn to after the U.S. Food and Drug Administration approved Airsupra on Wednesday.

The drug is the f...

06 Jan
FDA Approves Second Alzheimer’s Drug, Despite Safety Concerns

FDA Approves Second Alzheimer’s Drug, Despite Safety Concerns

The U.S. Food and Drug Administration on Friday approved a second Alzheimer's drug, lecanemab, despite reports of rare brain bleeds linked to use of the drug in some patients.

However, the FDA pointed to the drug's benefits, as well.

“Alzheimer’s disease immea...

05 Jan
Patients, Doctors Await FDA Decision on Experimental Alzheimer’s Drug

Patients, Doctors Await FDA Decision on Experimental Alzheimer’s Drug

Lecanemab: It's an experimental medication that's been shown in trials to slow cognitive decline in people with Alzheimer’s disease.

It's also up for accelerated approval by the U.S. Food and Drug Administration, with a decision expected by Jan. 6.

However, the...

02 Jan
Drug Approved to Help Young Patients Battle a Rare Cancer

Drug Approved to Help Young Patients Battle a Rare Cancer

Children and adults with a rare type of soft tissue cancer will now have a new treatment option that could have a big impact.

The U.S. Food and Drug Administration has

29 Dec
Congressional Report Slams FDA, Drugmaker Over Approval of Alzheimer's Drug Aduhelm

Congressional Report Slams FDA, Drugmaker Over Approval of Alzheimer's Drug Aduhelm

The U.S. Food and Drug Administration's approval process for the controversial Alzheimer's drug Aduhelm was "rife with irregularities," despite lingering doubts about the power of the pricey medication to slow the disease down, a Congressional report released Thursday claims.<...

26 Dec
Buyer Beware: Bogus Flu Meds Are Out There

Buyer Beware: Bogus Flu Meds Are Out There

With flu rampant in the United States, the U.S. Food and Drug Administration is warning consumers to be wary of over-the-counter products that promise to cure you of influenza, prevent it or reduce its severity.

Sellers offering these products may make claims that a...

22 Dec
Tough New Labeling Law for Sesame Prompts Companies to Add It to Their Products

Tough New Labeling Law for Sesame Prompts Companies to Add It to Their Products

Call it a good idea that seems to have backfired: A tough new labeling law that requires even the smallest amount of sesame be listed on food products has instead spurred some companies to add it to their products.

The

20 Dec
FDA's Tobacco Unit Overloaded and Lacking Direction, Panel Says

FDA's Tobacco Unit Overloaded and Lacking Direction, Panel Says

The U.S. Food and Drug Administration's tobacco unit is “reactive and overwhelmed,” an expert panel reviewing its work reported Monday.

In addition, the panel blamed the FDA's inconsistent regulation efforts for the spread of unauthorized e-cigarettes that are appeal...

19 Dec
FDA Approves Gene Therapy for Tough-to-Treat Bladder Cancer

FDA Approves Gene Therapy for Tough-to-Treat Bladder Cancer

Patients with a high-risk bladder cancer now have a new option to treat it.

The U.S. Food and Drug Administration on Friday approved a gene therapy called Adstiladrin, which is designed to work for patients who have what's called high-risk non-muscle-invasive bladder can...

09 Dec
Cats Now Have an FDA-Approved Pill to Treat Their Diabetes

Cats Now Have an FDA-Approved Pill to Treat Their Diabetes

Owners whose cats have diabetes now have a new option to care for the condition in their otherwise healthy pets.

The U.S. Food and Drug Administration on Thursday

08 Dec
FDA OKs Bivalent COVID Boosters for Kids 6 Months and Older

FDA OKs Bivalent COVID Boosters for Kids 6 Months and Older

The updated bivalent COVID-19 boosters are now approved for use in children as young as 6 months of age, the U.S. Food and Drug Administration announced today.

Children can receive either a Moderna or Pfizer-BioNTech bivalent booster shot, although the rules differ depen...

08 Dec
Lasik Surgery Should Carry Warnings of Possible Complications, FDA Says

Lasik Surgery Should Carry Warnings of Possible Complications, FDA Says

Lasik eye surgery is a common vision-correcting procedure that many Americans view as safe and effective, but the U.S. Food and Drug Administration has now drafted guidance that warns of potential complications.

Although many patients are happy with the results after sur...

08 Dec
Is a Ban on Menthols Enough to Thwart Big Tobacco?

Is a Ban on Menthols Enough to Thwart Big Tobacco?

A proposed U.S. federal ban on menthol cigarettes doesn't go far enough and needs to include other menthol products, from pipe tobacco to cigarette tubes, researchers say.

New evidence shows both the appeal and the addiction potential of these substitutes in adults who ...

07 Dec
FDA's Food Safety Program Needs a Revamp: Panel

FDA's Food Safety Program Needs a Revamp: Panel

The U.S. Food and Drug Administration's foods program is in “constant turmoil” and needs stronger leadership, a panel said Thursday.

The Reagan-Udall Foundation, a group with close ties to the FDA, released a 51-page

06 Dec
Banning Flavored Vapes Didn't Spur Folks to Quit

Banning Flavored Vapes Didn't Spur Folks to Quit

When the U.S. Food and Drug Administration banned fruit-flavored vaping products in early 2020, the idea was to reverse the rapid rise in electronic cigarette use among youths.

Now, a new survey of adult e-cigarette users finds that instead of quitting e-cig...

05 Dec
Pfizer Asks FDA to Approve Tweaked COVID Booster as Third Shot for Kids Under 5

Pfizer Asks FDA to Approve Tweaked COVID Booster as Third Shot for Kids Under 5

Infants and young children could soon receive an updated COVID-19 vaccine as part of their three-dose series.

Pfizer Inc. on Monday asked the U.S. Food and Drug Administration to have the vaccine that targets the Omicron subvariants BA.4 and BA.5 replace the third dose ...

01 Dec
First FDA-Approved Fecal-Based Treatment Helps Fight a Tough Superbug

First FDA-Approved Fecal-Based Treatment Helps Fight a Tough Superbug

The U.S. Food and Drug Administration on Wednesday approved the first fecal microbiota treatment, aimed at helping adults battling tough-to-treat Clostridium difficile (C. diff) infections.

"Today's approval of Rebyota is an advance in caring f...

01 Dec
FDA Moves to Ease Restrictions on Gay Men Giving Blood

FDA Moves to Ease Restrictions on Gay Men Giving Blood

U.S. Food & Drug Administration policies that have limited blood donations from men who have sex with men may soon ease.

At the moment, FDA policy does not allow blood donation from men who have had sex with other men in the past three months. That's already a shorter ti...

28 Nov
Berry Good for You: Some Foods Can Strengthen Your Brain

Berry Good for You: Some Foods Can Strengthen Your Brain

Eating more berries and drinking tea may help slow mental decline as you age, new research suggests.

In a study of more than 900 adults, researchers found that foods like these -- containing antioxidant flavonols -- delivered brain benefits to older adults. Flavono...

23 Nov
A Gene Therapy for Hemophilia That Costs $3.5 Million Gets FDA Approval

A Gene Therapy for Hemophilia That Costs $3.5 Million Gets FDA Approval

People with one form of the genetic blood disorder hemophilia now have a one-time treatment with a $3.5 million price tag.

The U.S. Food and Drug Administration approved the new gene therapy Hemgenix on Nov. 22. Soon after, drugmaker CSL Behring revealed its cost.

18 Nov
FDA Approves First Drug to Delay Onset of Type 1 Diabetes

FDA Approves First Drug to Delay Onset of Type 1 Diabetes

The U.S. Food and Drug Administration on Thursday approved the first drug that could delay the development of type 1 diabetes (T1D).

Teplizumab (Tzield) targets the autoimmune issues that drive the disease, rather than its symptoms, making the medication a game changer.<...

18 Nov
Using an Online Pharmacy to Buy Meds? It's Buyer Beware, FDA Says

Using an Online Pharmacy to Buy Meds? It's Buyer Beware, FDA Says

It might be tempting to buy prescription medication online, but buyers should beware, the U.S. Food and Drug Administration warns.

While some pharmacy websites operate legally and can offer convenience, privacy and lower costs, others may be selling unapproved, counterfe...

17 Nov
FDA Approves First Lab-Grown Meat Product

FDA Approves First Lab-Grown Meat Product

Americans could soon be eating chicken that's grown in a lab from cultured animal cells, rather than raised at a farm or facility.

The U.S. Food & Drug Administration