FDA
Analysts called the approval a much-needed win for Novo Nordisk, but warned that the company could struggle to grow sales once rival drugs come to market.
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Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.
With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former regulator insists that a “failed trial is not a failed drug.”
Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant, which it rejected last September, triggering a very public dispute with the company.
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Johnson & Johnson’s partner, Legend Biotech, has been awarded FDA approval for its (CAR-T) therapy, Carvykti, for the treatment of multiple myeloma disease.
The FDA declined approval for Amryt Pharma’s therapeutic oleogel-S10. The topical gel is intended to treat a group of rare skin diseases called epidermolysis bullosa.
The FDA lifts its clinical hold on Ocugen’s COVID-19 vaccine, and Ocugen announces a clinical trial for the treatment of inherited retinal diseases.
The latest EUA adjustment was based on findings that Evusheld might not be as active against certain subvariants of Omicron, but it could be if the dosage is increased.
Eli Lilly’s Jardiance scores expanded heart failure approval from the FDA and will now be available to all patients with heart failure to reduce the risk of death and hospitalization.
The FDA’s decision to approve Purdue’s drug Nalmefene earned mixed reactions, especially as the company is in the middle of lawsuits. Here’s what you need to know.
With IND approval, the therapeutics have become the first LBPs for Parkinson’s disease cleared by the FDA.
A new packaging and labeling manufacturing facility has derailed the potential approval of Malinckrodt’s investigational hepatorenal syndrome (HRS) treatment, terlipressin.
The end of February picks up significantly from early this year for the U.S. Food and Drug Administration and its PDUFA dates.
Bayer is heading back to the FDA to seek approval for a new indication of its prostate cancer drug Nubeqa, following positive Phase III results.