An advisory panel to the U.S. Food and Drug Administration on Wednesday voted resoundingly against recommending a stem cell-based experimental treatment for ALS.

Although the FDA isn't bound by the votes of its advisory panels, agency scientists have already penned a scathing review of the drug, called NuOwn.

Th...

Ozempic, a type 2 diabetes drug that has increasingly been used to help with weight loss, will now be labeled as having the potential to block intestines.

The U.S. Food and Drug Administration recently made the label update for the drug made by ...

A Pfizer plant that makes vital drugs, anesthesia and hospital supplies has restarted production after a 10-week shutdown.

The plant, located in Rocky Mount, N.C., sustained severe tornado damage on July 19, when roofs were ripped off and medications tossed around.

"This expedited restart is a proud achievement for the Rocky Mount team; however, it is only the first step toward ful...

Kraft Heinz said it is recalling over 83,000 packs of its Kraft Singles American processed cheese slices because of a packaging defect in the plastic that wraps the cheese slices.

A temporary issue developed on one of the wrapping machines, making it possible for a thin strip of individual film to stay on the cheese slice after the wrapper is removed. Having this film on the cheese could ...

A new government report finds that federal regulators need to do more to help in the battle to keep kids and teens off tobacco.

Among the report's findings were that the U.S. Food and Drug Administration needs to get tough on retailers selling tobacco to youth and should improve its oversight of online retailers.

The FDA should also work with the Bureau of Alcohol, Tobacco, Firearm...

In a surprising move, the U.S. Food and Drug Administration (FDA) has opted not to approve a needle-free alternative to the EpiPen for emergency treatment of severe allergic reactions.

Approval of the Neffy nasal spray was widely anticipated. An FDA advisory panel voted to recommend approval of the drug for children and adults in May. While the FDA is not obligated to follow the advice of...

Another diabetes drug maker is taking legal action against businesses in several states, alleging that they're “fraudulently claiming” that their compounded products are the same as its medication.

This time, it's Eli Lilly suing certain medical spas, wellness centers and compounding pharmacies over its medication Mounjaro.

Mounjaro contains the active ingredient tirzepatide an...

Following on an approval granted Monday by the U.S. Food and Drug Administration, an expert panel from the U.S. Centers for Disease Control and Prevention on Tuesday also signed off on new COVID boosters for Americans.

Final approval is expected from CDC Director Dr. Mandy Cohen, which would set the stage for the updated vaccines to soon become available.

The COVID-19 shots from Pf...

For decades, sick people have been taking essentially worthless over-the-counter cold remedies to clear their stuffy noses, a key advisory panel for the U.S. Food and Drug Administration said Tuesday.

The panel voted unanimously that nonprescription oral medications containing phenylephrine -- including Sudafed PE, Vicks Sinex and Benadryl Allergy Plus Congestion -- don't do anything to e...

The U.S. Food and Drug Administration on Monday gave the green light to new COVID boosters for Americans, setting the stage for the updated vaccines to become available within days.

The COVID-19 shots from Pfizer and Moderna will join the flu shot and newly approved RSV shots as part of a three-pronged public health strategy to tame the spread of all three viruses this coming winter. The ...

New COVID-19 booster shots could soon pass the needed hurdles for vaccinations to begin next week.

Sources familiar with U.S. Food and Drug Administration plans say boosters could be approved as soon as Friday, NBC News reported.

The U.S. Centers for Disease Control and Prevention Advisory Committee on Immunization Practices is scheduled to meet on Tuesday. CDC director

The U.S. Department of Health and Human Services has asked the U.S. Drug Enforcement Agency to reclassify marijuana as a less dangerous drug under the Controlled Substances Act, a move that could potentially expand acceptance of the drug.

The DEA confirmed receiving an Aug. 29 letter requesting the change and will begin its own review, a spokesperson told Bloomberg News.

Th...

Tainted eye drops are back in the news, with federal regulators warning consumers not to use certain eye drops because of contamination concerns.

The U.S. Food and Drug Administration on Tuesday

The U.S. Food and Drug Administration has warned that consumers should not use certain pregnancy, ovulation, urine, UTI and breast milk test kits over concerns that the tests may not be safe and effective.

The tests in question were manufactured by Universal Meditech Inc. (UMI), though they were branded under several names and may not include information about UMI on their packaging, the ...

Whether you got a tattoo on a whim or after much thought, that ink on your body is fairly permanent.

Tattoo removal is possible, but it comes with risks, according to the U.S. Food and Drug Administration, which regulates tattoo ink and pigment, as well as the laser devices used to remove them. State and local authorities typically oversee tattooing practices.

The FDA has cleared se...

The U.S. Food and Drug Administration on Friday approved a new pill, called zuranolone, that may quickly ease severe postpartum depression and help millions of women regain their emotional equilibrium following childbirth.

Taken as a pill once a day for two weeks, zuranolone (Zurzuvae) showed “rapid, significant and sustained” reductions in depressive symptoms when compared to a place...

A Louisiana woman is suing the makers of two type 2 diabetes drugs used off-label for obesity, saying they failed to adequately warn about the risk of severe stomach problems.

The lawsuit seeks “very significa...

While demand for prescription stimulants is surging, a shortage of the drugs persists, so federal officials have stepped in and asked drug companies to ramp up production of the medications.

Officials from both the U.S. Food and Drug Administration and the U.S. Drug Enforcement Administration (DEA) made the joint request.

“The FDA and DEA do not manufacture drugs and cannot requir...

All eyes are on the U.S. Food and Drug Administration this week as the agency weighs approval of a new pill that may quickly treat and ease severe postpartum depression.

Approval of the drug could help millions of women regain their emotional equilibrium following childbirth. The FDA's decision is expected by Friday.

Taken as a pill once a day for two weeks, zuranolone showed “ra...

Eight healthy habits could add years to your life.

A new study of more than 700,000 U.S. veterans breaks down the habits that when adopted by middle age, can help someone live substantially longer than folks who don't have these habits.

These are the big eight:

• Be physically active.
• Don't smoke.
• Don't get addicted to opioids.
• Don't binge-drink on a...

Another experimental drug meant to slow the damage of Alzheimer's appears poised to join a growing arsenal of new treatments for this memory-robbing disease.

In research published online Monday in the Journal of the American Medical Association and presented simultaneously at the Alzheimer's A...

The U.S. Food and Drug Administration on Thursday approved the nation's first over-the-counter birth control pill, a move that will likely pave the way for far greater access to contraception for Americans.

Women will be able to buy the progestin-only oral contraceptive at drug stores, convenience stores and grocery stores, the FDA said. There is no age limit.

Opill, which is made b...

The U.S. Food and Drug Administration on Thursday gave full approval to the Alzheimer's drug Leqembi, clearing the way for insurance coverage of the pricey drug.

“The full FDA approval will open the floodgates for people with early Alzheimer's to get this drug. It's a big deal because it's very expensive at $26,500 per year,"