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The FDA’s Division of Pharmaceutical Quality Operations hit repackager Loxha with a warning letter for lacking stability data and other GMP failures. Read More
A drugmaker in the Czech Republic was listed on the EudraGMDP inspection database for serious deficiencies at its Prague facility including the presence of mold and dead insects. Read More
EPH Technologies was slapped with an FDA warning letter for marketing unapproved drugs, including a product it claimed would relieve opioid withdrawal symptoms.
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In a move to fend off a generic competitor, Merck hit Accord Healthcare with a patent infringement suit in a Delaware federal court over Accord’s generic version of its blockbuster diabetes drug Januvia (sitagliptin phosphate).
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In observance of the Thanksgiving holiday, Drug Industry Daily will not be published Thursday, Nov. 28, or Friday, Nov. 29. The next issue will be published Monday, Dec. 2. Read More
Federal prosecutors have opened a criminal investigation into whether pharmaceutical companies violated the federal Controlled Substances Act (CSA), which is usually used to prosecute drug dealers. Read More