Samsung Gets First U.S. Approval April 26, 2017 By Christine Blank The second Remicade biosimilar is only the fifth biosimilar approved in the United States. NECC and the Future of Compounding Pharmacy April 18, 2017 By Nicholas Hamm Compounding pharmacist's case hinged on whether he was "willfully indifferent." Potential blockbuster arthritis drug delayed Citing safety concerns, FDA delayed approval of a new blockbuster drug to treat rheumatoid arthritis. How Drug Companies use Loopholes to Delay Generic Drug Approvals April 17, 2017 By Nicholas Hamm The citizens petition process is being used to delay approval of generic drugs. Uro Pipeline: FDA accepts two supplemental applications for mUC agent April 06, 2017 By Ben Schwartz Other pipeline developments include efficacy results for a bladder and prostate cancer drug, an infertility tool to predict sperm quality, the initiation of an immunotherapy combination for mUC, and more. EpiPen and EpiPen Jr. Recalled: Recall Expanded from Europe and Asia Two previous reports of device failures lead EpiPen maker to expand recall to the United States. Incremental clinical advances for Duchenne Muscular Dystrophy March 31, 2017 By Bryant Furlow Just last year, the FDA approved Exondys 51 (eteplirsen) for DMD, over the recommendations of FDA scientists and an external scientific advisory committee. Read more. Expedited FDA approval plays dominant role in drug approvals March 30, 2017 By Bryant Furlow Last year was a banner year for generic drug approvals by the FDA. Find out what’s in store for 2017. Five things to know about Trump’s FDA lead pick Gottlieb March 24, 2017 By Karen Appold On March 10, the White House announced that President Donald Trump selected Scott Gottlieb, MD, who has worked for FDA in the past, as his choice to head the FDA. Here are five things managed healthcare executives should know about the pick. First drug for rare skin cancer wins approval FDA approved the first treatment for metastatic Merkel cell carcinoma (MCC), a rare, aggressive skin cancer.