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While accelerated approval (AA) is a valuable and appropriate path for many promising drugs, for others — particularly those that don’t finish or even start confirmatory trials after they win approval — it’s a thorn in the FDA’s side. Read More
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