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Incomplete cGMP records, active ingredient testing and quality unit shortcomings prompted the FDA to issue a warning letter to Bingbing Pharmaceuticals, an OTC drugmaker in Hubei, China. Read More
Recro Pharma announced that the FDA granted its appeal of a complete response letter to an NDA for its intravenous pain medication meloxicam. Read More
Aquestive submitted a citizen petition to the FDA urging the agency to delay approval of Neurelis’ new drug application for its cluster seizure nasal spray Valtoco (diazepam intranasal solution) pending additional clinical studies. Read More
The FDA on Tuesday approved Sandoz’s Ziextenzo (pegfilgrastim-bmez), marking the agency’s 24th biosimilar approval and the third biosimilar of Amgen’s Neulasta. Read More
Data integrity and quality violations netted OTC drugmaker AMO Hangzhou a Form 483 following an FDA inspection of its facility in Hangzhou, Zhejiang. Read More
A coalition of HIV advocacy groups challenged an attempt by Gilead Sciences to get out of a federal lawsuit against HIV drugmakers accused of delaying competition from generics and branded products. Read More
HHS on Friday submitted its proposed rule on prescription drug imports — a key part of the administration’s strategy to lower drug prices — to the Office of Management and Budget (OMB) for review. Read More