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Exelixis expects to submit an NDA by the end of this year for cabozantinib to treat advanced renal cell cancer, following the receipt of FDA breakthrough therapy designation for use in patients who have received one prior therapy. Read More
The FDA has granted rare pediatric disease designation to two investigational Duchenne Muscular Dystrophy therapies — Sarepta Therapeutics’ eteplirsen and BioMarin Pharmaceutical’s drisapersen — the first DMD candidates to win the designation. Read More
A first-of-its-kind “basket study” of responses to Daiichi Sankyo and Genentech’s Zelboraf on a host of cancer mutations is showing positive results, Memorial Sloan Kettering Cancer Center researchers report. Read More
Pfizer has released positive topline results of two Phase 3 studies of its meningitis vaccine Trumenba, saying its ability to provoke an immune response and safety data are consistent with the findings that formed the basis for its FDA accelerated approval. Read More
Boehringer Ingelheim and Eli Lilly’s diabetes drug Jardiance reduced the risk of cardiovascular events in adults with Type 2 diabetes who are at high risk of such events, making it the only glucose-lowering agent to demonstrate this benefit in a dedicated trial. Read More
HHS has contracted with San Diego-based Pfenex Pharmaceuticals to develop an anthrax vaccine that is effective after exposure — under an agreement valued at up to $143 million. Read More