FDA panel calls to loosen restrictions on testosterone replacement therapy

The drugs have soared in popularity, with some men taking them for unapproved uses like anti-aging or increasing muscle mass.
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Expand Labeling for Testosterone Replacement Therapy, FDA Panel Says

Members of an FDA expert panel urged the agency to expand labeling for testosterone replacement therapy and remove its ...

US FDA approves first at-home device for depression

The U.S. Food and Drug Administration has approved Flow Neuroscience's at-home brain stimulation device to treat depression, ...

FDA opens safety review of injectable RSV drugs approved for babies and toddlers

Food and Drug Administration officials have opened a safety review of two injectable drugs used to protect babies and ...

Cheese Recall Sparks Highest FDA Risk Warning

Vulnerable groups such as pregnant women, older people and those with weakened immune systems are most at risk.

FDA reviewing safety of RSV drugs for infants, no incidents reported

Federal regulators have begun a safety review of two RSV medicines used to protect infants, even though no safety problems ...

Botulism outbreak tied to ByHeart formula sickens more than 50 babies in 19 states, FDA says

Health officials say an infant botulism outbreak tied to ByHeart baby formula has been expanded to include all illnesses ...

FDA approves first gene therapy for rare immune disorder

The U.S. Food and Drug Administration said on Tuesday it had approved the first gene therapy for a rare and life-threatening ...