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The FDA is seeking up to nine drugmakers to participate in a four-month pilot project to examine whether final submission of risk evaluation and mitigation strategies can be made more accessible to the public. Read More
Despite its lucrative promise, the U.S. Food and Drug Administration’s priority review voucher program has done little to spur development of novel treatments for tropical and rare pediatric diseases, a new study in JAMA concludes. Read More
Despite its lucrative promise, the FDA’s priority review voucher program has done little to spur development of novel treatments for tropical and rare pediatric diseases, a new study in JAMA concludes. Read More
Roche’s ocrelizumab proved effective in treating primary progressive multiple sclerosis in a Phase 3 study, making it the first investigational drug to show positive results for both PPMS and relapsing remitting MS. Read More
Amgen and Allergan claim their biosimilar candidate for Roche’s blockbuster Avastin is clinically equivalent in adult patients with advanced non-small cell lung cancer. Read More