The National Institute for Health and Care Excellence has issued its final draft guidance for Kadcyla, which declares the drug is too expensive to cover.
Shares of Tekmira got a boost Thursday night after the company spread the word that the FDA had switched its full clinical hold on an experimental Ebola drug to a partial hold, clearing the path to its possible use to fight a sudden outbreak in Africa that has been sparking chilling headlines the world over.
As the regulatory climate for corporate tax inversions reaches a boiling point, Medtronic is facing heightened government scrutiny for its pending merger with Covidien.
Seattle's CTI BioPharma picked up the FDA's fast-track designation for pacritinib, a late-stage treatment for blood cancer.
A test-tube diagnostic developed by the U.S. military to screen for a specific strain of the Ebola virus has gained FDA authorization for emergency use.
Sales of Pfizer's best-selling vaccine may soon be getting bigger. The European Medicines Agency (EMA) has accepted the company's application to expand the label on Prevenar 13 in adults to include the prevention of pneumonia caused by the 13 pneumococcal serotypes the vaccine contains.
Backtracking on a positive decision it made four years ago, Britain's National Institute for Health and Care Excellence has dealt a blow to AstraZeneca by withdrawing its endorsement of the company's drug Iressa for the treatment of non-small cell lung cancer patients who have failed previous treatments.
Pfizer has cleared the decks of a marketing scandal that it inherited with its 2009 acquisition of Wyeth. The New York drugmaker will pay $35 million to 41 states and the District of Columbia to settle a case accusing it of pushing a kidney transplant drug for off-label uses.
Last year's surprising FDA rejection blew a hole in Novo Nordisk's plans to capitalize on a new long-acting insulin, but the Danish drugmaker said its follow-on study is coming through ahead of schedule, clearing the way for a 2016 launch.
More than 5 years after The Medicines Company bagged Targanta and its troubled antibiotic oritavancin for the bargain basement rate of $42 million plus potential bonus payments, the biotech has finally nailed down an elusive FDA approval of the product for skin infections caused by Gram-positive bacteria, including MRSA.