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The FDA rejected Genta’s new drug application (NDA) for Genasense plus chemotherapy in patients with chronic lymphomatic leukemia (CLL), the company announced.
The FDA is pledging to continue fighting an effort by wholesalers to stop the agency from implementing its drug-tracking rule, despite early setbacks in court.
The FDA’s Blood Products Advisory Committee has recommended that the agency not lift the clinical hold it has imposed on a clinical trial of Biopure’s blood substitute, Hemopure.
Members of a joint advisory committee voted to slash the approved uses for sanofi-aventis’ antibiotic Ketek and place a black box warning on its remaining indication.
The FDA may be facing increasing pressure on Capitol Hill due to its handling of Ketek, as a former agency official turned whistleblower is working with activists and a key Senate critic to take the FDA to task.
Rhein 83 must stop marketing its dental products in the U.S. because it lacks an approved premarket approval (PMA) application, an FDA warning letter said.
Clinical trial results for a heart device may be biased and new randomized clinical trials will be needed to improve the device's chances for FDA approval, agency officials said at an FDA panel meeting last week.
After examining risks related to the off-label use of drug-eluting stents, an FDA panel has recommended the agency consider mandating labeling changes.
OTC drugs in very small “convenience-size” packages could qualify for “optional alternative labeling” under a proposed amendment to the FDA’s 1999 final rule on standardized format and content requirements for OTC drug labeling in general.