The Best FDA Decision On Peptide Authorization Isn’t Yes Or No

The FDA is weighing whether six experimental peptides should become available through compounding pharmacies. A better answer ...

Two rejections, messy process: Replimune finally secures FDA approval for skin cancer treatment

The U.S. Food and Drug Administration (FDA) on Thursday granted accelerated approval to Replimune Group Inc. REPL for its ...

OncoSil Medical secures US FDA approval for OncoSil device, opening A$80 million annual market

OncoSil Medical Ltd (ASX:OSL, OTC:OCMLF) has secured US Food and Drug Administration (FDA) approval for its OncoSil™ targeted radiation device to treat distal cholangiocarcinoma (dCCA), giving the ...

A Major Step Was Just Taken to Make Peptides More Accessible. Is That a Good Thing?

Researchers, doctors, and former regulators break it down.
The American Journal of Managed Care

FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...
RAPS

Tougher FDA Approval Process for Opioids Sought by Congress

New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the US Food and Drug Administration (FDA). The ...
Opinion

FDA drug approval affects healthcare around the world, but political shortcuts could hurt the agency’s international reputation

At the beginning of July 2026, the U.S. Food and Drug Administration approved the first gene therapy for young children with sickle cell disease. While this is good news for children in the U.S. born ...

An FDA Committee Just Voted in Favor of Peptides—Despite the Agency's Opposition

The group met on July 24 to vote on whether compounding pharmacies could legally dispense certain peptides.