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After the challenges of global in-person facility inspections throughout the pandemic, the FDA is at the start of “a return to a steady state,” of onsite work, said an FDA assistant commissioner in the keynote address at the WCG-FDAnews’ 17th Annual Inspections Summit in Washington, D.C., on Thursday. Read More
The company believes the drug will inhibit C5 in patients with certain complement-mediated diseases. There is currently no cure for myasthenia gravis. Read More
A federal appeals court sided with AbbVie’s Pharmacyclics and Johnson & Johnson’s Janssen Biotech this week, affirming that a generic version of the blockbuster cancer drug Imbruvica (ibrutinib) infringes their patents. Read More
An FDA advisory committee voted 9-4 yesterday in favor of Ardelyx’s Xphozah (tenapanor) for adults with chronic kidney disease (CKD) who are on dialysis, despite some concerns over the drug’s efficacy. Read More
The settlement, if approved, will resolve the defendants’ alleged abuse of the generic pharmaceutical approval process under the Hatch-Waxman Act. Read More
Pfizer has picked up three allies in its legal battle to continue a financial support program that provides cash to help patients buy its extremely expensive heart medication, tafamidis. Read More
The Biden administration has asked a federal judge to dismiss claims that the FDA has intentionally delayed rendering a decision on a Florida proposal to import prescription drugs from Canada. Read More
The decision follows an FDA review of the final overall survival analysis of the phase 3 trial for the drug, which showed no risk reduction compared to the control treatment. Read More