The US Food and Drug Administration (FDA) has released a new draft guidance describing what should and should not be included in the Drug Interactions (DIs) section for human prescription drug and ...
The US Food and Drug Administration (FDA) has issued two draft guidance documents aimed at improving the consistency of labeling for both over-the-counter (OTC) and prescription drugs.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 ...
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 ...
A study found that 26% of uncertainties in cancer drug approvals are not included in FDA labels, with 48% being crucial to approval decisions. The FDA's current communication methods, such as drug ...
A common drug combo for Parkinson’s disease will require a new FDA warning after the agency flagged 14 cases of seizures in patients using the medications. The agency is mandating (PDF) that ...
The FDA is looking at a slew of label expansions this month, including one that could open up home-based treatments for ...
Hormone-based drugs used to treat hot flashes and other menopause symptoms will no longer carry a bold warning label about stroke, heart attack, dementia, and other serious risks, the Food and Drug ...
In a single day of sweeping actions, the FDA moved to expand treatment options for psychiatric conditions, including approving a broader use for lumateperone (Caplyta) in schizophrenia, fast-tracking ...
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