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Public Citizen has petitioned the FDA and the Drug Enforcement Administration to reclassify tramadol as a Schedule II controlled substance because of its high potential for abuse. Read More
Lipocine has received a third complete response letter from the FDA for its novel oral testosterone replacement therapy Tlando for treatment of male hypogonadism. Read More
The Danish Medicines Agency took action against a violative drugmaker by suspending its authorization to manufacture drugs and intermediates, following an inspection that revealed serious GMP violations. Read More
The FDA has revoked Indivior’s orphan drug designation for its opioid addiction treatment Sublocade (buprenorphine extended-release injection) finding that it was improperly granted. Read More
A New York judge has set a Jan. 20 trial date for opioid litigation led by the state’s attorney general against opioid manufacturers and distributors. Read More
The FDA, EMA and Japan’s Pharmaceuticals and Medical Devices Agency have made strides toward aligning clinical trial designs for antibacterial drug indications, the regulators announced following their fourth tripartite meeting in Tokyo. Read More