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The FDA has given Takeda’s Ninlaro the green light of approval in combination with other therapies to treat multiple myeloma in the second-line setting. Read More
The European Commission released new rules clarifying the responsibilities of qualified persons overseeing global, multisite manufacturing operations and the data they need to collect. Read More
The National Institute for Health and Care Excellence has given the green light to Bayer’s Xofigo in England and Wales as an option for treating adults with hormone-relapsed prostate cancer, symptomatic bone metastases and no known visceral metastases, albeit with restrictions. Read More
Despite agreeing that Telesta’s bladder cancer biologic candidate would offer limited side effects and low toxicity — maybe even less than standard of care — FDA reviewers voted against recommending it Wednesday because of a lack of proven benefit. Read More
Biosimilars experts concluded that fostering the nascent industry would require many of the same elements that originally nurtured the generics industry: educational efforts, regulatory and patent changes, and most importantly, patience. Read More
During clinical development, biosimilars makers can request as many meetings with FDA reviewers as necessary but they need to be outcomes-based with a priority on narrowly defined questions that the FDA can answer. Read More