May 21, 2025: NCHR’s Amanda Berhaupt testified at the FDA Advisory Committee that since the TALAPRO-2 trial shows Talzenna with Xtandi benefits castration-resistant metastatic prostate cancer patients with HRRm tumors but not those without, the FDA should not expand approval to HRRm-negative patients. The FDA Committee agreed.
Read More »Author: Caroline Bradford
NCHR Testimony on Glofitamab-gxbm at the FDA Oncology Drugs Advisory Committee
May 20, 2025: NCHR’s Amanda Berhaupt testified at the FDA Advisory Committee that since Glofitamab trial shows Asian patients with Diffuse Large B Cell Lymphoma patients do well but US and European patients do poorly and STARGLO had too few US patients to generalize results, the Genentech trial does not confirm safety and efficacy for DLBCL patients. The FDA Committee agreed.
Read More »Trump’s diversity purge freezes hundreds of millions in medical research at universities across the country
CNN reports how cuts in university research projects harm important efforts to improve health and save lives in red and blue states. NCHR says researchers are scared about the future of their work and explains how important it is to study differences in how patients develop diseases and which treatments are most effective. We suggest that studies using terms like diversity could be funded if described accurately but with different wording.
Read More »Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER
We agree with other experts who expect that as head of CBER at FDA, Vinay Prasad will improve FDA approval standards by making it harder for unproven drugs to get FDA approval. Patients deserve to be able to rely on FDA to make sure drugs and biologics being sold in the US are safe and effective. Patients and physicians can’t make well-informed decisions if companies don’t do the research needed to provide clear evidence that a medical product is safe and effective.
Read More »Rethinking “Antimicrobial Resistance” : Focusing on Patients instead of Pathogenic Organisms
Everyone knows about antibiotic resistance. In fact, the term “antimicrobial resistance” even has its own acronym: AMR. With all the attention and new antibiotics being developed, why are the number of deaths from infections still the same year after year? Our commentary was just published in an international medical journal, and we explain that the […]
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