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New Drug Safety Alliance, Website to Educate on REMS
October 22, 2015.
A new alliance has launched to educate the public, policymakers and other key stakeholders about Risk Evaluation and Mitigation Strategies (REMS). The Patients Alliance for Drug Safety Protections is comprised of 20 public health, patient advocacy, health professional and disease organizations. To underscore the value of REMS to public health, the Alliance unveiled a new online resource, www.drugprotections.org that translates the latest facts about the REMS program in layman's terms. Designed for ease of use, the online hub summarizes the history and purpose of REMS, what REMS entails and the number of medicines now marketed with a REMS. In addition, the website provides links to information about REMS from FDA and other reputable source and will serve as a clearinghouse for the coalition's policy materials.
Read the full release.
Johnson & Johnson Seeks FDA Approval for Subcutaneous Tremfya Regimen for Ulcerative Colitis
November 22nd 2024Johnson & Johnson has submitted a supplemental Biologics License Application to the FDA for a subcutaneous induction regimen of Tremfya for adults with moderately to severely active ulcerative colitis based on positive Phase III ASTRO trial results.
