Results for search "Food &, Drug Administration".
With the United States facing a high number of drug shortages, a Chinese company may help to boost the supply of one in particular, the chemotherapy agent cisplatin.
The U.S. Food and Drug Administration is working with the Chinese drugmaker Qilu Pharmaceutical to import the widely used cancer drug. The Canadian pharmaceutical company Apotex will distribute the medication in 50-milli...
It’s tempting to treat little skin bumps on your own, but that delays proper diagnosis and treatment that may work better, federal regulators cautioned.
Among the many types of skin conditions a person can contract are a virus called molluscum, which look like white, pink or flesh-colored bumps.
Products marketed as treatments for molluscum have not been approved by the U.S. Food ...
Older adults may have a second vaccine option for RSV following the U.S. Food and Drug Administration's approval of a Pfizer vaccine on Wednesday.
The other shot for adults 60 and up is made by GSK. It was approved May 3.
Both should be available by fall, before the seasonal spread of respiratory syncytial virus (RSV), The New York Times reported.
The Pfizer ...
Americans with COVID-19 have been taking Paxlovid since it was approved under emergency use in late 2021. Today, the U.S. Food and Drug Administration granted full approval to the drug.
This approval will allow drugmaker Pfizer to sell the medication at market rate once government supplies are used up.
Paxlovid is the fourth antiviral drug and first pill approved by the FDA to treat...
The U.S. Food and Drug Administration on Monday approved a second nasal spray for reversing an opioid overdose.
To be sold as Opvee, the spray contains the medication nalmefene hydrochloride and will be available to Americans aged 12 and older with a prescription, the FDA said.
"The agency continues to advance the FDA Overdose Prevention Framework and take actionable steps that enc...
Patients with Crohn’s disease have a new treatment option, following U.S. Food and Drug Administration approval of a pill called Rinvoq (upadacitinib).
Rinvoq is meant to treat adults with moderately to severely active Crohn’s disease who have not had success with TNF (tumor necrosis factor) blockers. The daily pill is the first oral treatment for this group of patients.
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It's important to ask questions when your doctor or dentist writes you a new prescription.
This is especially true for opioid pain medications, such as hydrocodone, oxycodone or morphine.
While these drugs are approved by the U.S. Food and Drug Administration for acute and chronic pain, they can have serious side effects, including addiction and even death.
Misuse of opioids ...
The U.S. Food and Drug Administration on Friday approved the first nonhormonal medication aimed at easing menopause hot flashes.
The new pill, called Veozah (fezolinetant), is from a class of drugs called neurokinin 3 (NK3) receptor antagonists. It targets a specific brain neuron that's thought to be set off balance as estrogen levels naturally decline during menopause.
"It works b...
Outside advisors for the U.S. Food and Drug Administration voted Thursday to recommend approval of Neffy, the first epinephrine nasal spray for severe allergic reactions.
Although most of the Pulmonary-Allergy Drugs Advisory Committee members supported the spray for adults (16:6) and children (17:5), key questions linger about whether more data is needed from its maker, ARS Pharmaceutical...
The U.S. Food and Drug Administration on Thursday finalized the elimination of certain restrictions that prevented healthy gay and bisexual men from donating blood.
Instead of requiring men who have sex with men or the women who have sex with them to abstain for sexual contact for three months, the FDA has created an individual risk assessment for all donors.
These questions are m...
A medication to treat agitation in Alzheimer's patients now has approval from the U.S. Food and Drug Administration.
The FDA gave supplemental approval to Otsuka Pharmaceutical Company Ltd., and Lundbeck Inc. for Rexulti (brexpiprazole) oral tablets on Thursday. Rexulti is the first FDA-approved treatment for these symptoms.
“Agitation is one of the most common and challenging asp...
In a unanimous vote, a panel of expert advisors to the U.S. Food and Drug Administration on Wednesday endorsed the over-the-counter sale of a birth control pill, a recommendation that will likely pave the way for far greater access to contraception for Americans.
Opill, as the pill is called, was first approved by the FDA in 1973. There is no precise information available on how much Opil...
As a U.S. Food Drug Administration advisory panel prepares to weigh whether to recommend that a birth control pill be sold over the counter in this country, a coalition of advocates on Monday called attention to the safety and effectiveness of the medication.
If approved, Opill, a daily progestin-only birth control pill, would become the first such drug sold over the counter in the United...
Danish drugmaker Novo Nordisk said Thursday it will limit distribution of its low-dose versions of the wildly popular weight-loss drug Wegovy, to ensure that people already taking the drug will have enough supply.
The medication is one of three drugs from a class known as GLP-1 agonists. These medications have been shown in studies to be effective for weight loss but have faced shortages...
Another experimental drug meant for Alzheimer's disease looks so promising that drugmaker Eli Lilly plans to ask the U.S. Food and Drug Administration for full approval by the end of June.
Known as donanemab, the medication clears amyloid plaque from the brain. In a late trial, the drug slowed memory and thinking declines in early symptomatic Alzheimer's patients by more than a third, Li...
U.S. regulators are urging Americans to avoid Apetamin, an illegal drug used for weight gain and figure enhancement.
The substance, typically sold as a syrup, is manufactured overseas, illegally imported and isn't approved by the U.S. Food and Drug Administration.
It contains a potent antihistamine called cyproheptadine, which requires a physician's prescription in the United State...
General Mills has recalled four varieties of its Gold Medal flour because of concerns over potential contamination with salmonella.
The recalled flour has “better if used by” dates of March 27, 2024, and March 28, 2024,
The U.S. Supreme Court ruled on Friday that the abortion pill mifepristone can remain widely available while litigation over its fate winds its way through the court system.
In the meantime, the order effectively halts a ruling from a federal judge in Texas that said th...
The Supreme Court on Wednesday delayed a decision on a federal appeals court ruling that seeks to limit access to the abortion pill mifepristone.
In a brief order, Justice Samuel Alito Jr. said the pause on any decision would lapse Friday at midnight, giving the court more time to consider the case, the New York Times reported.
The delay suggests there may be disagreemen...
In the latest move to restrict access to the abortion pill mifepristone in the United States, a coalition of anti-abortion groups on Tuesday asked the Supreme Court to allow an appeals court ruling to stand.
That ruling, issued by the Fifth Circuit Court of ...
Seniors and people with weakened immune systems can get another booster dose of the bivalent COVID vaccine this spring, the U.S. Food and Drug Administration announced Tuesday.
Seniors age 65 and older can get a booster at least four months following their first dose of the bivalent vaccine, which protects against both the original and Omicron strains of COVID, the FDA said. People with w...
The Biden administration filed an emergency application on Friday that asks the U.S. Supreme Court to pause parts of a recent federal ruling that limit the availability of the abortion pill mifepristone.
On Wednesday, a federal appeals court partially overruled Judge Matthew Kacsmaryk's ruling in Tex...
A federal appeals court on Wednesday said the abortion pill mifepristone could remain available for now. But the court's judges added some provisions to their ruling: A block on mailing the pill to patients as well as stays on other measures the federal government has taken recently to boost access to the medication.
The three-member panel partially overruled
Juul Labs on Wednesday reached a $462 million settlement with several states over the aggressive marketing of its electronic cigarettes to minors.
This latest settlement includes New York, California, Colorado, the District of Columbia, Illinois, Massachusetts and New Mexico.
Juul
The U.S. Justice Department on Monday appealed a Texas court ruling that invalidates the U.S. Food and Drug Administration's approval in 2020 of mifepristone, the first of two drugs taken during a medical abortion.
The ruling by U.S. District Judge Matthew Kacsmaryk in Texas is “extraordinary and u...
A Texas federal judge has issued a preliminary ruling that invalidates the U.S. Food and Drug Administration approval in 2000 of mifepristone, the first of two drugs most commonly taken during a medical abortion.
Judge Matthew Kacsmaryk added a seven-day stay to his order, issued Friday, to give the...
The U.S. Food and Drug Administration on Thursday formally withdrew its approval of a drug that was meant to prevent preterm births.
Sold as Makena, the drug was first approved in 2011 under the FDA's accelerated approval program, but subsequent research questioned the medication's effectiveness and noted serious side effects that included blood clots and depression.
"It is tragic t...
Cats constantly licking and chewing because of a skin condition called feline allergic dermatitis may benefit from a new generic treatment approved by the U.S. Food and Drug Administration.
The FDA approved Modulis for Ca...
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.
“The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, t...
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
A drug-resistant bacteria linked to recalled eye drops has now killed three people.
The U.S. Centers for Disease Control and Prevention reported Tuesday that infections with Pseudomonas aeruginosa had led to two additional deaths.
In all, 68 people have become infected in 16 states. ...
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 company's Gateway Eau Claire, Wisc., manufacturing facility.
No distributed products have tested positive for the bacter...
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 Pfizer drug remains a safe and effective treatment and should be given full approval. It has only received emergency use ...
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 (Zavzpret), a nasal spray meant to treat severe headache pain, the company announced Friday.
“The FDA approval of Zavzpret marks a significant breakthrough for pe...
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 risk factor for developing breast cancer.
The U.S. Food and Drug Administration update amends regulations issued u...
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 advisory panel vote last October that concluded the drug does not actually benefit newborns.
“While we stand by M...
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.
These recalls do not appear to be connected to other recent recalls or an outbreak in drug-resistant infections, the As...
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's safety isn't in question, just whether it actually does what it claims to do.
The FDA's Nonprescription Drugs Advis...
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 based largely on the results of a trial that tested the GlaxoSmithKline vaccine in the same age group. Those findings, publi...
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 reported to the FDA and the CPSC [U.S. Consumer Product Safety Commission]," the FDA said in a new
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 will weigh the potential approval of another respiratory syncytial virus (RSV) vaccine, this one from GlaxoSmithKline, on...
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 deer, the drug is not safe for people. It is sold on the street under the names tranq, Philly dope and zombie drug.
F...
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-cigarette industry, the societal concerns are not subtle," FDA Commissioner Dr. Robert Califf said in an agency news release...
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 released new draft rule...
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 opioid epidemic rages on in this country.
The FDA advisors voted unanimously in favor of making the drug easier to ...
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 pharmacist, CNN reported.
Approval could happen later this year. Research shows that wider availability of...
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
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.
"We're proposing the creation of a unified, newly envisioned organization, called the Human Foods Program, that el...