FDA Commissioner Robert Califf says the agency needs to improve how it makes use of advisory committees, likening them to artificial intelligence (AI) algorithms, which need constant input to function…

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studies by sponsors of neonatal medical products — whether a drug, biologic product or device — in a new draft guidance released…

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…

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…

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…

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)…

The FDA has updated its guidance on the compounding of ibuprofen oral suspension products to include state-licensed pharmacies and federal facilities. Source: Drug Industry Daily

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.…

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. Source:…

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. Source: Drug Industry Daily