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…

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…

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…

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:…

Elahere (mirvetuximab soravtansine-gynx), ImmunoGen’s antibody-drug conjugate for ovarian cancer, has received FDA accelerated approval — and the company has already completed enrollment for a confirmatory trial with topline results expected…

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.…