Glenmark Pharmaceuticals receives FDA warning letter for Indore facility, commits to resolving compliance issues promptly.

A warning letter is a serious communication from the USFDA that signifies a potential risk to public health or safety due to ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

FDA action aligns with a growing chorus of scientists, public health experts, and advocates warning against the public health ...

The White House asked companies to remove Red No. 3, an artificial color in candy and cereal, sooner than the 2027 deadline ...

While the complete response letter derails a near-term clearance, one analyst described the rejection as more of “a speed ...

The FDA has called a plan to publish certain complete response letters (CRLs) for medicines it has rejected after an initial ...

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...

By Stephanie Brown HealthDay ReporterTHURSDAY, July 10, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has ...

The agency said it issued the import alerts because it “continues to have concerns related to outstanding Quality System ...

Class II recalls from the FDA indicate a potential risk to consumer safety where use or exposure to the product may cause ...

Endoscopy devices restricted from import accounted for about 1% of the company’s consolidated revenue in its latest fiscal ...