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The FDA has issued two complete response letters (CRL) to Phathom Pharmaceuticals, one for a new drug application (NDA) for its acid suppressant vonoprazan for treating erosive esophagitis and another for a postapproval supplement for Voquezna, a combination therapy previously approved for treating Helicobacter pylori infections. Read More
The FDA highlighted the need for long-term neurodevelopmental studies by sponsors of neonatal medical products — whether a drug, biologic product or device — in a new draft guidance released Friday. Read More
The FDA has updated its guidance on the compounding of ibuprofen oral suspension products to include state-licensed pharmacies and federal facilities. Read More
FDA Commissioner Robert Califf responded to questions from members of the House Energy and Commerce Committee this week about the agency’s response to the COVID-19 pandemic, including their concerns about the agency’s ability to oversee the pharmaceutical supply chain. Read More
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Drugmakers have asked for several clarifications in the draft guidance the agency released in December on the use of statistical approaches in bioequivalence (BE) studies.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.