Medline (Nasdaq:MDLN) has received a warning letter from the FDA related to NAMIC brand angiographic control syringes and ...

After Medline pulled off a massive $6.26 billion IPO late last year, the company now finds itself facing serious concerns ...

In the latest tranche of published warning letters, the US Food and Drug Administration (FDA) has continued to go after ...

The FDA this month issued a warning letter to ImmunityBio regarding promotional statements about cancer drug Anktiva that the agency claims are “false or misleading.” The missive marks the first ...

The enforcement action was announced alongside President Donald Trump's signing of a presidential memorandum.

The FDA warned against purchasing certain hyaluronic acid products for pain relief, citing potentially dangerous undeclared ...

The US Food and Drug Administration (FDA) has warned an oncology drug company for repeatedly overstating the efficacy of its drug in advertisements while failing to adequately disclose the associated ...

By Rishika Sadam April 9 (Reuters) - Granules India is increasing oversight at its manufacturing facilities and digitising documents after the U.S. drug regulator flagged violations, including issues ...

FDA made clear that comments from ImmunityBio founder Dr. Patrick Soon-Shiong about prescription drugs in longform audio can trigger enforcement just like TV or digital ads. Regulators evaluated the ...

According to the FDA, ImmunityBio’s communications “create a misleading impression” that Anktiva can cure or prevent cancer ...

A common drug combo for Parkinson’s disease will require a new FDA warning after the agency flagged 14 cases of seizures in patients using the medications. The agency is mandating (PDF) that ...