C&EN

March 13 Policy Watch: FDA streamlines its process for approving biosimilar drugs

In another development, 25 states have petitioned to join a lawsuit and defend the EPA’s decision to rescind the climate endangerment finding ...
Medical News Today

What does FDA approval mean? A guide to understand the process

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

FDA reversals leave investors worrying about the fates of other experimental drugs

Investors are scrutinizing the prospects for some drugs in the pipeline following a string of recent rejections from the U.S.
Fierce Biotech

UniQure shares crash 40% as FDA rejects early approval path for Huntington's gene therapy

Shares of uniQure plummeted more than 40% in premarket trading Monday after the company confirmed the FDA has rejected its current data package for AMT-130, a highly anticipated gene therapy for ...
Fierce Pharma

Novo lands another FDA untitled letter, this time for Apple-inspired Ozempic ad

Not long after Novo Nordisk received an untitled letter from the FDA disputing certain elements of the first TV spot for its ...
Politifact

A product says it's ‘FDA approved,’ ‘FDA registered’ or ‘FDA certified.’ What does that even mean?

An Instagram ad catches your eye. You click to the product’s website and find reassurance: The product, it says, is "FDA certified" or was "produced in an FDA registered facility." Mention of the U.S.