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AstraZeneca’s kinase inhibitor Iressa received FDA approval Monday as the first and only first-line treatment for patients with metastatic non-small cell lung cancer whose tumors have certain types of gene mutations, along with a companion diagnostic. Read More
The FDA’s Oncologic Drugs Advisory Committee largely appeared to agree that Eli Lilly’s lung cancer drug necitumumab offers some late-stage lung cancer patients increased survival time, despite an increased risk of adverse events, but didn’t vote on whether to recommend the product for approval. Read More
Teva said Wednesday that it has launched a generic version of Janssen Pharmaceutical’s migraine drug Axert in the U.S., following receipt of FDA approval. Read More
The FDA is clarifying when drugmakers should seek formal and informal presubmission meetings with the Office of Orphan Products Development, in an effort to save time and resources. Read More
The FDA Tuesday approved Novartis’ heart failure drug Entresto, which had received priority review and fast track designations to expedite therapies for life-threatening conditions and unmet medical needs. Read More
Purdue Pharma has withdrawn its supplemental new drug application for reformulated OxyContin, causing cancelation of an FDA advisory committee meeting to discuss whether postmarket studies of the product’s extended-release tablets show reduced misuse. Read More
Vertex Pharmaceuticals’ Orkambi has been approved as the first drug intended to treat cystic fibrosis in patients who have two copies of a specific mutation, the FDA announced Friday. Read More
Gilead Sciences has submitted an NDA for a once-daily single tablet regimen to treat HIV-1 infection in adult and pediatric patients 12 years and older, using a priority review voucher that it acquired from Knight Pharmaceuticals for $125 million in November 2014. Read More