FDA Commissioner Robert Califf said yesterday that the FDA is taking new steps to address the ongoing opioid crisis, but emphasized that there’s only so much the agency can accomplish…

The Regenerative Stem Cell Institute — a Chicago company with eight branches — may need to secure a biologics license to continue treating patients with adipose cell-derived stem cells, the…

The FDA has sent both Teva Pharmaceuticals and France-based MedinCell a Complete Response Letter regarding their joint new drug application (NDA) for TV-46000/mdc-IRM, their extended-release formulation of risperidone for the…

For the vast majority of Americans, the most practical COVID-19 vaccination program would be a primary series of two doses plus a booster and an extra booster given every fall,…

Pfizer’s novel antiviral nirmatrelvir plus ritonavir cut the risk of COVID-19-related death or hospitalization by 89 percent relative to placebo, a phase 2/3 study has determined. Source: Drug Industry Daily

National Cancer Institute (NCI)-designated centers are marking up oncology drugs by as much as 633 percent over the acquisition cost, according to a new cost analysis. Source: Drug Industry Daily

Plastikon Healthcare’s drug manufacturing facility in Lawrence, Kan., drew an 11-observation Form 483 following an FDA inspection in late October-early November that identified several testing and documentation failures. Source: Drug…

Mumbai, India-based generic drugmaker Lupin has received another Form 483 inspection report from the FDA. Source: Drug Industry Daily

Three FDA investigators observed multiple quality lapses during a more than two-week inspection of Noven Pharmaceuticals’ transdermal drug manufacturing plant in Miami, Fla in November 2021. Source: Drug Industry Daily

Johnson & Johnson (J&J) has agreed to pay $99 million to settle allegations that its Janssen subsidiary helped facilitate the opioid epidemic in West Virginia, just weeks after a trial…