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...

The U.S. Food and Drug Administration is once again warning consumers to avoid muscle-building "supplements" that are anything but a safe alternative to steroids.

In an advisory sent out last week, the agency said it continues to ...

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,