Here is a recap of every FDA approval announced by the regulatory agency in the month of April, spanning various cancer types ...

Pharmacists say some safeguard programs for risky medications have stopped, basic information about others is unavailable ...

The FDA is expected to decide on treatments for bullous pemphigoid, hereditary angioedema, HIV PrEP, ovarian cancer, and RSV.

When the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a recent Notice of Violation (“NOV”), some of us ...

The Missouri Senator is demanding changes to mifepristone two weeks after his wife's employer launched an attack on birth ...

TLX101-CDx is an investigational positron emission tomography agent that targets the membrane transport proteins, LAT1 and LAT2.

Inspectors found ICU Medical made multiple changes to infusion pumps without submitting premarket notifications.

Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, including by ...

The US Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its Covid-19 ...

Medical device maker ICU Medical changed the designs of infusion pumps made in Minnesota without properly clearing important ...

Pharmaceuticals announced on Friday the Food and Drug Administration has issued a complete response letter regarding the ...