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The FDA has approved Octapharma’s Nuwiq, an intravenous therapy that treats bleeding in children and adults with hemophilia A with congenital factor VIII deficiency. Read More
President Obama announced late Tuesday his intention to nominate Robert Califf as the next commissioner of the FDA, capping a swift rise for the respected clinical researcher, who assumed the agency’s number two role — deputy commissioner for tobacco and medical products — in March. Read More
The FDA’s Vaccines and Related Biological Products Advisory Committee offered nearly unanimous support of CSL’s influenza vaccine Fluad, recommending the agency approve an accelerated pathway for use in people 65 and older against influenza types A and B. Read More
The FDA has released a final guidance allowing it to destroy certain drug imports valued at $2,500 or less that have been refused admission into the country in an attempt to boost the integrity of the drug supply chain. Read More
The FDA has banned imports of drugs made at Mumbai-India based Polydrug Laboratories, marking the latest development in ongoing issues involving Indian manufacturers. Read More
The FDA has granted Catabasis Pharmaceuticals a rare pediatric disease designation for an investigational drug used to treat Duchenne Muscular Dystrophy, paving the way for priority review, the company said Monday. Read More
The GPhA is challenging the legality of the FDA’s final guidance calling for generics makers to design tablets and capsules to be similar in size and shape to their reference drug to ensure patient acceptance. Read More
Merck KGaA has informed the European Medicines Agency that it will apply for marketing authorization for its multiple sclerosis drug Cladribine, four years after the firm withdrew its application following a negative opinion from the Committee for Medicinal Products for Human Use. Read More
The FDA’s Vaccines and Related Biological Products Advisory Committee will meet today to discuss the safety and immunogenicity of CSL’s influenza vaccine Fluad to determine if it should be approved through an accelerated approval pathway. The vaccine is proposed for use in people 65 and older as treatment against influenza types A and B. Read More
Raptor Pharmaceuticals says it does not plan to develop its liver drug, RP103, after it missed the primary endpoint in a Phase 2b study for nonalcoholic steatohepatitis in children. Read More
Sanofi’s LixiLan met the primary endpoint in a pivotal Phase 3 trial showing a greater drop in average blood glucose in diabetes patients when combined with Lantus (insulin glargine). Read More