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The FDA approved a second gene therapy for cancer, adding Kite Pharma’s lymphoma treatment Yescarta (axicabtagene ciloleucel) to the fledgling list. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use had a light meeting load this month, recommending approval for a single generic medicine and expansions of indications for six other drugs. Read More
The FDA will agree to meet to discuss the ANDA deficiencies cited in a complete response letter to a sponsor only if the sponsor lists the questions it wants to raise and the people who will participate in the meeting and includes other items spelled out by the agency in draft guidance, the FDA said. Read More
The FDA said that if an applicant requests a teleconference, the FDA will conduct the teleconference and decide 90 percent of the requests within 30 days. Read More
The European Medicines Agency is implementing a new form to submit required postmarket data on safety, efficacy and quality, and it is now a mandatory part of Module 1.0 of the electronic common technical document format. Read More
The European Medicines Agency hit a snag in its efforts to publish clinical trial data reports, due to long pilot phases for the first publications it made after the policy took effect last October. Read More
The European Medicines Agency revised its 2009 advice to sponsors seeking evaluations of products intended exclusively for markets outside the EU. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended thirteen products, including its first biosimilar for Genentech’s blockbuster drug Herceptin. Read More