We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
AstraZeneca and Peregrine Pharmaceuticals are collaborating on an early-phase clinical trial to evaluate the safety and efficacy of two novel investigational drugs in patients with a range of solid tumor types. Read More
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 proposal includes accelerated approvals of drugs, specified timelines for deciding applications and increased public access to information. Read More
The FDA is requiring additional warnings on the labeling of Leo Pharma’s Picato topical gel for actinic keratosis after receiving reports of severe allergic reactions and shingles associated with its use. Read More
The European Medicines Agency is seeking feedback on the International Conference on Harmonization’s revised E6 guideline, which adds new recommendations for sponsors on developing risk-based quality management systems for clinical trials. 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