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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 treatment of patients with schizophrenia. Read More
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 FDA has said in an untitled letter. Read More
Johnson & Johnson (J&J), Endo Pharmaceutical and drug distributor McKesson have agreed to pay approximately $276 million to settle allegations that they contributed to the opioid epidemic in Alabama. Read More
The FDA first approved Enhertu in 2019 for patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. Read More
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. Read More
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. Read More
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 got under way in the state. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) has issued draft guidance for industry on developing medicines that can be used for the treatment of celiac disease (CeD) along with a gluten-free diet. Read More