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Ensuring that data and records generated for medical products are secure, trustworthy and of high quality throughout the whole R&D process is a pivotal concern today, with data integrity violations rising and many moving parts threatening to put data at greater risk than ever before. Read More
After half a century of serving the regulatory information needs of the pharmaceutical, medical device and biologics communities, FDAnews presents the final issue of its flagship publication today. Read More
Rare disease advocacy groups often use the phrase “rare is not rare” to drive home the point that although individual diseases and conditions might affect only a small number of people, together they constitute a large patient population. Read More
A new pooled analysis published in The Lancet demonstrated a reduced risk of combined cardiovascular death or worsening heart failure when treated with semaglutide. Read More
The FDA has issued a request for information (RFI) for advancing model-informed drug development (MIDD) to assist CDER and CBER in identifying and prioritizing potential focus areas for future policy or guidance development. Read More
Citing ethical and data concerns, four US lawmakers have begun an investigation into clinical research conducted jointly by American biopharma firms and the Chinese military, as well as trials run in China’s Xinjiang region, where the US claims a genocide is being carried out against the area’s Uyghur population. Read More
In this edition of Quick Notes, we look at positive news on development of drugs and treatments for multiple myeloma, RSV and follicular lymphoma as well as the discontinuation of an unsuccessful trial in treating extensive-stage small cell lung cancer. Read More
Drastic changes in drug development mean quality management approaches are more critical than ever, with meaningful advancement hinging on cultural shifts, cross functional alignment and top-down approaches within organizations, as well as thoughtful, stakeholder-informed trial designs. Read More
A cohort study recently published in JAMA Network Open has found that Eli Lilly’s blockbuster antidiabetic drug Zepbound (tirzepatide) is linked to lower risks of major complications compared to GLP-1 receptor agonist (RA) drugs, suggesting additional clinical boons for the highly sought medication. Read More
The FDA has issued two new guidances on the development of oncology drugs and biologics, posting a final guidance on optimizing cancer drug doses and a draft guidance on developing drugs specifically for Bacillus Calmette-Guérin-unresponsive nonmuscle invasive bladder cancer. Read More
The FDA has provided a case study of how CDER used machine learning to identify a suitable patient population for a COVID-19 treatment that was approved under the emergency use authorization (EUA). Read More
In this edition of Quick Notes, we provide a look at the first dissolvable oral contraceptive, good news for Pfizer’s hemophilia A gene therapy, approval of a new treatment for multiple myeloma and a clinical hold on a Type 1 diabetes therapy. Read More