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Drugmakers have a long way to go when it comes to fulfilling their required postmarket reporting, according to the FDA’s most recent numbers. Read More
The European Medicines Agency (EMA) is requesting public comment on its new multi-stakeholder platform, Accelerating Clinical Trials (ACT) EU, for improving clinical trials within the trade bloc. Read More
Sage Therapeutics and Biogen announced Monday that the FDA has given priority review to the companies’ new drug application (NDA) for zuranolone for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Read More
In a case with wide-ranging implications for how broad patent protections can be, Sanofi and Regeneron are calling on the Supreme Court to deny Amgen’s attempt to overturn an appeals court’s rejection of Amgen’s patent for its blockbuster cholesterol treatment Repatha (evolocumab). Read More
More than two years after receiving an FDA rejection, Mesoblast has resubmitted its biologics license application (BLA) for remestemcel-L, a treatment for children afflicted with steroid-refractory acute graft vs. host disease (SR-aGVHD). Read More
The FDA has warned consumers not to use EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination that has caused permanent vision loss from eye infections and one death. Read More
As the Biden administration prepares to end the COVID-19 public health emergency on May 11, the FDA must decide what to do with dozens of temporary guidances issued during the public health emergency. Read More
In this special report, Drug Industry Daily examines how the drug supply chain has evolved during the pandemic. Part 2 focuses on efforts to shore up the supply chain, including the promotion of domestic manufacturing.Read More
Becoming — and remaining — in compliance with FDA regulations is often a result of creating and maintaining a quality culture but measuring the maturity of that culture takes more than just looking at metrics, according to several experts speaking at a recent FDAnews webinar. Read More