High Court’s ‘Skinny Label’ Ruling Boosts Patent Case Defenses

The US Supreme Court’s recent ruling protecting generic-drug “skinny labels” has the potential to give technology, ...

Supreme Court Protects ‘Skinny Label’ Generic Drug Pathway (2)

The Supreme Court said a district court judge was right to dismiss Amarin Pharma Inc.'s infringement suit over claims its ...

US Supreme Court backs generic drugmaker in 'skinny label' patent case

By Blake Brittain WASHINGTON, June 4 (Reuters) - Drugmaker Hikma's generic version of Amarin Pharma's cardiovascular ...
The Hill

Tylenol maker: possible FDA label change ‘unsupported by scientific evidence’

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 ...
RAPS

FDA drafts guidance on drug interaction labeling

The US Food and Drug Administration (FDA) has released a new draft guidance describing what should and should not be included in the Drug Interactions (DIs) section for human prescription drug and ...