The U.S. Food and Drug Administration has approved a label expansion for Axsome Therapeutics’ (AXSM) depression therapy Auvelity, allowing its use as a treatment for agitation associated with dementia ...

The US Food and Drug Administration (FDA) has issued two draft guidance documents aimed at improving the consistency of labeling for both over-the-counter (OTC) and prescription drugs. One of the ...

AbbVie ABBV announced that it has submitted a regulatory filing to the FDA seeking approval for a new indication of its ...

There has been no shortage of tension between the US Food and Drug Administration (FDA) and generic drug manufacturers as of late. And if a recent spat between FDA and Hospira is any indication, don't ...

The FDA is requiring safety labeling changes to all opioid painkillers, to better highlight the risks posed by using the drugs long-term. The changes come after a public advisory committee meeting in ...

FDA drug alerts in infectious diseases, including new drug approvals, safety warnings, recalls, and changes in indications.

After years of off-label use, veterinarians now have the first FDA-approved amlodipine formulation specifically indicated for ...

WASHINGTON - The U.S. Food and Drug Administration plans to approve a new use for the generic drug leucovorin as a treatment for kids with autism. Trump, Health and Human Services Secretary Robert F.

Developed by Australian biotech company Snoretox in collaboration with Royal Melbourne Institute of Technology (RMIT) ...

The US Food and Drug Administration (FDA) held a 2-day public hearing this week to solicit input about the marketing and use of medications and medical devices for off-label use. It is fairly common ...