FDA Chief Makary Defends Agency’s Rigorous Rare Disease Drug Review Process WASHINGTON – Food and Drug Administration Commissioner Robert Califf’s successor, Marty Makary, has publicly defended the agency’s recent decisions to deny approval for several treatments targeting rare diseases. In a televised interview with CNBC on Thursday, Makary staunchly supported the judgment of FDA officials, … Read more
Grail’s Galleri Cancer Screening Test Shows Limited Benefit in Landmark Study, Stock Plummets Shares of Grail, the biotech firm pioneering multi-cancer early detection (MCED) tests, experienced a dramatic 50% decline following the release of initial data from a pivotal clinical trial of its Galleri blood test. While the study did not achieve statistical significance in … Read more
The line between consumer wellness technology and regulated medical devices has become increasingly blurred in recent years. From earbuds offering enhanced audio clarity to smartwatches tracking vital signs, the proliferation of health-related features in everyday electronics has prompted a critical review by the U.S. Food and Drug Administration (FDA). On January 6, 2026, the FDA … Read more
Every two minutes, someone in the US is diagnosed with cancer. But what if that diagnosis could be delivered with unprecedented speed and accuracy, and tailored to the individual’s unique genetic makeup? That future is rapidly approaching, driven by breakthroughs in artificial intelligence. From accelerating pathology analysis to predicting drug responses, AI is poised to … Read more
CDC Grant Fuels Controversy Over Hepatitis B Vaccine Trial Linked to FDA Official WASHINGTON – The Centers for Disease Control and Prevention (CDC) has awarded a $1.6 million grant to researchers at the University of Southern Denmark, a move drawing scrutiny due to the researchers’ connections to a high-ranking Food and Drug Administration (FDA) official, … Read more
FDA Broadens Approval of Addyi for Women Experiencing Sexual Desire Issues After Menopause The Food and Drug Administration (FDA) has expanded the approved use of Addyi (flibanserin), a medication designed to treat hypoactive sexual desire disorder (HSDD) in women, now including those who have completed menopause. This decision offers a potential new option for women … Read more
The Dawn of Proactive Alzheimer’s: From Blood Tests to Smart Homes, a New Era of Early Detection Every 65 seconds, someone in the United States develops Alzheimer’s disease. But what if we could shift from reactive care to proactive prevention? Recent breakthroughs – FDA approvals for blood tests, increasingly accurate cognitive assessments via everyday technology, … Read more
FDA Drug Approval Process Under Scrutiny: Leadership Intervention Raises Concerns Washington – A recent shift in the Food and Drug Administration’s (FDA) process for reviewing drugs granted Commissioner’s National Priority Vouchers is sparking debate and raising questions about potential political influence. The FDA had pledged expedited reviews – typically one to two months – for … Read more
FDA Greenlights Wave of AI-Powered Medical Innovations, Transforming Patient Care The U.S. Food and Drug Administration (FDA) has recently authorized a significant number of cutting-edge medical technologies, signaling a pivotal shift towards artificial intelligence (AI) and advanced diagnostics in healthcare. These clearances promise to enhance precision, reduce invasiveness, and broaden access to critical medical services. … Read more
Washington D.C. – In a move hailed by patient advocates and industry leaders, the Food and Drug Administration has appointed Dr. Richard Pazdur as the new Director of the Center for Drug Evaluation and Research (CDER). The announcement, made today, signals a potential turning point for the agency, which has recently faced increased scrutiny and … Read more