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 ...

ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), a U.S. based, end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, ...

The FDA is looking at a slew of label expansions this month, including one that could open up home-based treatments for Alzheimer’s disease.

Tylenol maker Kenvue is calling on the Food and Drug Administration (FDA) to back off a proposed safety label change to acetaminophen after the Trump administration linked its use during pregnancy to ...

A new study found that an FDA “healthy” label could influence what foods shoppers choose and how much they’re willing to pay.

Fluorouracil is not recommended for use in patients known to have certain homozygous or compound heterozygous DPYD variants that result in complete DPD deficiency. The Food and Drug Administration ...

Study finds FDA-backed "healthy" labels increase healthier snack purchases and price premiums, highlighting the commercial ...

Amyvid can now be used to aid in the selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information. The Food and Drug Administration (FDA) has ...

The FDA is removing a long-standing warning from hormone-based drugs used to treat menopause symptoms in women. FDA and HHS officials said the labels stemmed from a study published more than 20 years ...