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CDER Director Janet Woodcock came under fire Thursday from senators demanding to know why the FDA is years behind Europe and Canada in establishing a workable program for biosimilars. Read More
President Obama’s nomination of Robert Califf to lead the FDA is drawing praise from those in industry and academia who see him as an outstanding choice and a strong leader deeply respected by the scientific community. Read More
The FDA issued a warning letter to Coram Healthcare over its Crownpoint, Ind., facility for serious deficiencies in producing sterile drug products. Read More
The FDA has clarified prescribing information for antipsychotic drug clozapine, explaining how to monitor and manage treatment of patients with neutropenia. Read More
California-based biopharmaceutical companies Amgen and Xencor entered into a research and license agreement that could be worth as much as $1.7 billion to develop and commercialize therapeutics focused on cancer immunotherapy and inflammation. Read More
Amgen is acquiring Dutch biotechnology company Dezima Pharma for $300 million plus up to $1.25 billion in milestone payments, the companies announced Wednesday. Read More
The FDA awarded Bristol-Myers Squibb’s Opdivo a breakthrough therapy designation for metastatic renal cell carcinoma, adding another potential indication to the growing list for the PD-1 inhibitor. Read More
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