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Salix Pharmaceuticals and Progenics Pharmaceuticals said they had received FDA clearance for a new indication on their opioid-induced constipation drug Relistor. Read More
The FDA has signed off on a new formulation of Otsuka and Lundbeck’s collaborative anti-psychotic Abilify Maintena to be delivered via pre-filled dual chamber syringe. Read More
The FDA will continue to combat abuse of central nervous system-stimulating drugs like Ritalin and Adderall on a case-by-case basis, the agency said, rejecting a long-standing citizen petition that had called for a reformulation of the entire drug class. Read More
Sponsors developing therapies for rare pediatric diseases must pay the FDA roughly $2.6 million to use a priority review voucher in the new fiscal year that starts today. Read More
Impax has agreed to pay shareholders $8 million to end a class action lawsuit alleging the brand and generics maker deliberately withheld the extent of its manufacturing practice violation problems. Read More
FDA investigators and their European counterparts are comparing training and auditing procedures as the first steps in a new push to increase mutual reliance on each other’s inspections. Read More
Regulators in Japan have proposed changes to the standards for using biological ingredients during the manufacture of pharmaceuticals, quasi-drugs and medical devices. Read More
Alimera Sciences has won FDA approval of its eye drug Iluvien after several years of negotiations with the agency to address potential safety concerns. Read More