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…

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…

The FDA has approved Eli Lilly’s Rezvoglar (insulin glargine-aglr) as the second interchangeable biosimilar insulin on the U.S. market. Source: Drug Industry Daily

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…

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…

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…

Aarkish Pharmaceuticals received a nine-observation Form 483 for missing records and other quality lapses observed during an inspection of its Fairfield, N.J., facility. Source: Drug Industry Daily

Sellas Life Sciences is amending the statistical analysis in an ongoing phase 3 trial for acute myeloid leukemia after a preliminary data review found that patients enrolled were living twice…

The FDA is considering whether some versions of the overdose reversal drug naloxone may be approvable for nonprescription use. Source: Drug Industry Daily

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. Source:…