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Drugmakers should notify the FDA and any affected trading partner within 24 hours of encountering suspected counterfeit products to prevent or limit them from entering or being distributed in the supply chain, the agency says in a notice published in Tuesday’s Federal Register. Read More
Indian active pharmaceutical ingredient maker Pan Drugs Limited was hit with an FDA warning letter after an inspection revealed data integrity issues and significant cGMP violations, leading the company to announce it would sell its product locally. The company will stay on the FDA’s Import Alert list until it makes the corrections. Read More
Janssen and Pharmacyclics have submitted an sNDA for Imbruvica for front-line treatment for chronic lymphocytic leukemia, which, if approved, would provide patients who have not been treated with an alternative to chemotherapy. Read More
XenoPort announced its Phase 2 clinical trial of an experimental drug for patients with moderate-to-severe chronic psoriasis met its primary endpoints. Read More
FDA has placed a hold on clinical trials of long-term cognitive treatment encenicline after some patients experienced serious gastrointestinal concerns, Forum Pharmaceuticals and its Japanese partner reported. Read More
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