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ViGuard Health called on the FDA to declare pyridoxamine to be a dietary supplement and no longer authorized for investigation as a new drug. Read More
The FDA issued a warning letter to Chinese drugmaker Guangdong Zhanjiang Jimin Pharmaceutical following a May inspection of its Guangdong Province facility. Read More
The Federal Circuit upheld two Sanofi patents for its antiarrhythmic drug Multaq (dronedarone) — agreeing with Sanofi’s argument that the drug’s label, which is required to be similar for any generic versions, would ultimately direct physicians to violate the company’s patent on using Multaq to prevent abnormal heart rhythms. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended ten medicines for approval, including two orphan medicines and a new treatment for multiple sclerosis. Read More
Senate Republicans released a competing tax reform plan that — in comparison to the House side’s proposed repeal — merely shrinks the size of the orphan drug research tax credit. Read More
Ensuring data integrity is a crucial task for drug manufacturers wishing to stay out of trouble with the FDA, a top enforcement official at the agency told an industry conference. Read More
The FDA cited an outsourcing drug compounder in Arkansas for failure to meet sterile production standards, according to a warning letter from the agency. Read More