The leading publisher of FDA News, FDA Review, FDA Compliance, QSR News, and Food Drug Administration information since 1984. http://fdaweb.com/ Mon, 8 Jun 2026 23:44:14 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161274 PhRMA calls on FDA to provide clearer regulatory expectations for the use of digital health technologies in drug development, arguing that adoption has lagged despite years of agency guidance and industry investment. Mon, 8 Jun 2026 10:43:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161274 http://fdaweb.com/login.php?sa=v&aid=D5161273 FDA approves an expanded indication for Pfizer's hemophilia treatment Hympavzi (marstacimab-hncq), allowing its use in additional patient populations. Mon, 8 Jun 2026 10:38:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161273 http://fdaweb.com/login.php?sa=v&aid=D5161271 FDA issues an early alert warning healthcare providers about a potentially high-risk defect affecting certain infant resuscitation systems manufactured by GE HealthCare. Mon, 8 Jun 2026 10:01:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161271 http://fdaweb.com/login.php?sa=v&aid=D5161270 FDA launches a new effort to aggregate clinical trial data on kidney safety biomarkers, seeking pharmaceutical industry participation in a pilot program that could ultimately broaden the agency's use of a novel "biomarker incubator." Mon, 8 Jun 2026 09:00:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161270 http://fdaweb.com/login.php?sa=v&aid=D5161269 FDA officials are seeking to bolster confidence in generic medicines, highlighting the agency's oversight of drug manufacturing, inspection programs and post-market surveillance while promoting new efforts to expand domestic pharmaceutical production. Mon, 8 Jun 2026 06:33:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161269 http://fdaweb.com/login.php?sa=v&aid=D5161268 Former FDA enforcement official suggests new strategies for industry to prepare for agency inspections that rely on artificial intelligence tools. Mon, 8 Jun 2026 05:37:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161268 http://fdaweb.com/login.php?sa=v&aid=D5161267 FDA approves a Lupin BLA for Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar to Genentech's blockbuster eye drug Lucentis. Fri, 5 Jun 2026 11:49:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161267 http://fdaweb.com/login.php?sa=v&aid=D5161266 FDA says its breakthrough devices program has surpassed 1,280 designations since its launch, highlighting the growing use of the expedited pathway by medical device developers seeking to bring innovative technologies to patients with serious or life-threatening diseases. Fri, 5 Jun 2026 11:11:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161266 http://fdaweb.com/login.php?sa=v&aid=D5161265 FDA issues Xspray Pharma a complete response letter for the company's NDA for Nilopki, an improved formulation of nilotinib designed to compete with Novartis' chronic myeloid leukemia therapy Tasigna. Fri, 5 Jun 2026 10:48:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161265 http://fdaweb.com/login.php?sa=v&aid=D5161264 The House passes FDA’s appropriations bill for fiscal year 2027 that provides $7.1 billion for the agency. Fri, 5 Jun 2026 08:58:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161264 http://fdaweb.com/login.php?sa=v&aid=D5161263 Stakeholders at FDA's public hearing on the Commissioner’s National Priority Voucher program urge the agency to temporarily suspend the initiative and establish a more transparent framework governing its operation. Fri, 5 Jun 2026 07:56:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161263 http://fdaweb.com/login.php?sa=v&aid=D5161262 FDA releases a draft guidance outlining post-approval responsibilities facing manufacturers of generic drugs, highlighting requirements ranging from adverse event reporting and drug shortage notifications to labeling updates, promotional material submissions and compliance with Risk Evaluation and Mitigation Strategies. Fri, 5 Jun 2026 06:08:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161262 http://fdaweb.com/login.php?sa=v&aid=D5161261 Former FDAers Richard Pazdur and Nicole Gormley promote ways to restructure the agency so it can be more independent and successful. Thu, 4 Jun 2026 11:42:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161261 http://fdaweb.com/login.php?sa=v&aid=D5161260 The Senate Special Committee on Aging hears testimony on how an unsecure U.S. drug supply chain is harming older patients. Thu, 4 Jun 2026 11:24:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161260 http://fdaweb.com/login.php?sa=v&aid=D5161259 U.S. House lawmakers introduce bipartisan legislation aimed at expanding federal scrutiny of U.S. investments in China's biotechnology sector, arguing that American capital and expertise are accelerating the growth of a strategic industry that could undermine U.S. economic and national security interests. Thu, 4 Jun 2026 11:22:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161259 http://fdaweb.com/login.php?sa=v&aid=D5161258 A Friends of Cancer Research white paper recommends three ways the FDA Biomarker Qualification Program could be improved. Thu, 4 Jun 2026 10:46:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161258 http://fdaweb.com/login.php?sa=v&aid=D5161257 FDA posts a guidance outlining its intent to exempt several low-risk, unclassified medical devices from premarket notification requirements. Thu, 4 Jun 2026 10:28:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161257 http://fdaweb.com/login.php?sa=v&aid=D5161256 The U.S. Supreme Court hands a victory to Hikma Pharmaceuticals in a closely watched case testing the patent risks of FDA-approved "skinny label" generics, rejecting Amarin Pharma's infringement claims involving the cardiovascular drug Vascepa Thu, 4 Jun 2026 10:21:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161256 http://fdaweb.com/login.php?sa=v&aid=D5161255 Radiopharmaceutical drug manufacturers say they need more consistency from FDA in inspections and regulatory operations. Thu, 4 Jun 2026 09:46:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161255 http://fdaweb.com/login.php?sa=v&aid=D5161254 FDA acting commissioner Kyle Diamantas, who is rumored to be under consideration to be named commissioner, meets with rare disease community advocates in an effort to rebuild a fractured relationship. Thu, 4 Jun 2026 08:11:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161254