FDA

Samsung Gets First U.S. ApprovalThe second Remicade biosimilar is only the fifth biosimilar approved in the United States.
NECC and the Future of Compounding Pharmacy
NECC and the Future of Compounding PharmacyCompounding pharmacist's case hinged on whether he was "willfully indifferent."
Potential blockbuster arthritis drug delayedCiting safety concerns, FDA delayed approval of a new blockbuster drug to treat rheumatoid arthritis.
How Drug Companies use Loopholes to Delay Generic Drug Approvals
How Drug Companies use Loopholes to Delay Generic Drug ApprovalsThe citizens petition process is being used to delay approval of generic drugs.
Uro Pipeline: FDA accepts two supplemental applications for mUC agentOther 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 AsiaTwo previous reports of device failures lead EpiPen maker to expand recall to the United States.
Incremental clinical advances for Duchenne Muscular DystrophyJust 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 approvalsLast 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 GottliebOn 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 approvalFDA approved the first treatment for metastatic Merkel cell carcinoma (MCC), a rare, aggressive skin cancer.