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The FDA has given Blueprint Medicines the go-ahead to begin Phase I clinical trials for its investigational BLU-285 and BLU-554 to treat gastrointestinal tract, liver and biliary duct cancers. Read More
The UK’s healthcare costs regulator is recommending Daiichi Sankyo’s oral anticoagulant Lixiana as a cost-effective drug that causes less disruption to patients’ lives while treating blood clots in deep veins that could lead to fatal blockages. Read More
The European Medicines Agency has initiated a review of human papillomavirus vaccines to determine if product information should be updated, following reports of rare but serious conditions that may be associated with their use. Read More
Otsuka and H. Lundbeck expect to launch once-daily Rexulti as a treatment for schizophrenia and add-on therapy for major depressive disorder in early August, following FDA approval Monday. Read More
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
AstraZeneca has sold global rights, excluding the U.S., to its Entocort gastroenterology drug to Tillotts Pharma for $215 million, as it focuses on cancer and diabetes therapies. Read More
The FDA’s Office of Prescription Drug Promotion has warned Herndon, Va., drugmaker ASCEND Therapeutics US for distributing promotional cards about its EstroGel product that omit important risk information. Read More
Bipartisan leaders of the House Energy & Commerce Committee are asking the FDA why extended-release opioids require black box warnings and immediate-release versions of the painkillers do not. Read More
A study of nearly 28,000 women linked antidepressants Paxil and Prozac to a small increase in birth defects, but cleared three other antidepressants of such concerns. Read More
The FDA is requiring stronger label warnings for non-aspirin nonsteroidal anti-inflammatory drugs, after a comprehensive review of new safety information affirmed an increased risk of heart attack or stroke. Read More
The House of Representatives Friday approved the 21st Century Cures Act by a vote of 344 to 77, moving focus to the Senate where efforts have begun to develop comparable legislation. Read More