Axsome wins FDA label expansion for Auvelity in Alzheimer’s agitation

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 ...

Why a Supreme Court Case on ‘Skinny Labeling’ Matters for Drug Costs

The case, Hikma v. Amarin, centers on ‘skinny labeling,’ a pathway that allows generic drugs to come to market faster.
Axios on MSN

Supreme Court takes up generic drug labeling fight

Supreme Court justices on Wednesday will hear arguments in a patent case that could change the way generic drug companies ...
STAT

Supreme Court justices appear to signal ‘skinny labeling’ can survive

After months of anticipation, Supreme Court justices heard arguments about a long-standing tactic used by generic companies ...
AOL

FDA relaxes labeling rules on 'no artificial colors' claims amid crackdown

The U.S. Food and Drug Administration (FDA) announced Thursday it will relax federal regulations regulating when companies may label products as free of artificial coloring. The FDA said businesses ...
RAPS

FDA Proposal Calls for Drug Labeling to be Distributed to Doctors Electronically

In a long-anticipated and major move, the US Food and Drug Administration (FDA) has proposed a new rule requiring biopharmaceutical companies to distribute product labeling information to healthcare ...
RAPS

FDA's Battles Over Generic Drug Labeling Continue on a Smaller Scale

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 ...

Study Shows FDA ‘Healthy’ Label Boosts Demand for Healthier Snacks

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

FDA Issues Draft Guidance on Labeling of Plant-Based Alternatives to Animal-Derived Foods

On January 6, 2025, the U.S. Food and Drug Administration (FDA) issued draft guidance on the labeling of plant-based alternatives to animal-derived foods. The draft guidance provides best practices ...

How a Supreme Court fight over fish oil could raise your prescription drug costs

The justices are set to hear Hikma v. Amarin, a battle over drug patents that could raise costs for patients and change the ...
Medscape

FDA Safety Labeling Changes: April-June 2017

Adverse reactions so serious in proportion to the potential benefit from the drug that it is essential that it be considered in assessing the risks and benefits of using the drug; OR Serious adverse ...
The Hill

Food companies want to confuse consumers. The FDA must push back.

The “Make America Healthy Again” agenda has catapulted nutrition issues to the forefront of conversations about Americans’ health. The policy proposals range from getting junk foods out of schools to ...