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The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 8 to 5 on Thursday to recommend allowing GSK to move forward with a single-arm trial to evaluate its immunotherapy dostarlimab-gxly (dostarlimab) for the treatment of patients with mismatch repair deficiency/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer (LARC). Read More
A single injection of Eiger Biopharmaceuticals’ peginterferon Lambda, an immune defense-stimulating protein, cut the rate of COVID-19 hospitalization by 51 percent compared to placebo, researchers reported in the New England Journal of Medicine. Read More
Galapagos reported disappointing topline results from a phase 3 trial of its Janus kinase (JAK) inhibitor filgotinib for patients with moderate to severe Crohn’s disease (CD) and said it will not file for marketing authorization in Europe. Read More
Drugmakers have asked for several clarifications in the draft guidance the agency released in December on the use of statistical approaches in bioequivalence (BE) studies.
A Florida district judge said Tuesday that the nearly 50,000 complaints filed against multiple drugmakers alleging Zantac (ranitidine) causes cancer cannot form larger multi-plaintiff injury cases and must proceed individually.
The European Medicines Agency’s (EMA) policy on interchangeability of biosimilars relates only to the active substance and formulated product, the agency said in a clarifying statement.
An Italian manufacturer of injectable drugs, Laboratorio Italiano Biochimico Farmaceutico Lisapharma, earned a Form 483 after an FDA inspection turned up evidence of microbiological contamination in supposedly sterile drugs.