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Lupin has again run afoul of the FDA, drawing a Form 483 over deficiencies observed at its injectable drug manufacturing plant in Nagpur, Maharashtra, India, following a pre-approval inspection conducted from Oct. 17 to 29. Read More
More than 150 industry organizations and drugmakers have submitted a letter to Congressional leaders urging passage of the Pasteur Act, a languishing bill first introduced in 2020 to incentivize development of new treatments for combating drug-resistant pathogens. Read More
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