The leading publisher of FDA News, FDA Review, FDA Compliance, QSR News, and Food Drug Administration information since 1984. http://fdaweb.com/ Thu, 23 Jul 2026 17:59:38 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161512 Johnson & Johnson reports promising topline results from the three-arm investigational Phase 3 MonumenTAL-6 study evaluating Tecvayli (teclistamab-cqyv) and Talvey (talquetamab-tgvs) in adult patients with relapsed or refractory multiple myeloma. Thu, 23 Jul 2026 12:02:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161512 http://fdaweb.com/login.php?sa=v&aid=D5161511 A just-posted Form FDA 483 cites SGS France Life Sciences following an 8/2025 inspection, identifying multiple deficiencies involving bioanalytical method validation, study documentation and adherence to standard operating procedures at a facility in France. Thu, 23 Jul 2026 11:24:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161511 http://fdaweb.com/login.php?sa=v&aid=D5161510 FDA releases the form FDA-483 issued following a 2026 inspection at the CSL Behring biological drug manufacturing facility in Marburg, Hessia, Germany. Thu, 23 Jul 2026 11:17:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161510 http://fdaweb.com/login.php?sa=v&aid=D5161509 Attorney Megan Robertson’s analysis of 2026 FDA Warning Letters shows that CDER has been the most active Center, going after telehealth companies selling compounded GLP-1s and CGMP issues in foreign and domestic manufacturers. Thu, 23 Jul 2026 11:14:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161509 http://fdaweb.com/login.php?sa=v&aid=D5161508 FDA accepts for review Revolution Medicines' NDA for daraxonrasib, an investigational oral RAS-targeted therapy for patients with previously treated metastatic pancreatic ductal adenocarcinoma. Thu, 23 Jul 2026 11:13:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161508 http://fdaweb.com/login.php?sa=v&aid=D5161507 The Senate HELP Committee advances legislation sponsored by Sen. Rand Paul that he says will speed approval of biosimilar drugs by eliminating requirements that sponsors perform unnecessary tests. Thu, 23 Jul 2026 11:00:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161507 http://fdaweb.com/login.php?sa=v&aid=D5161506 Former FDA commissioner Rob Califf tells a cardiology technology convention that the U.S. needs to make significant changes to improve population health outcomes. Thu, 23 Jul 2026 09:38:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161506 http://fdaweb.com/login.php?sa=v&aid=D5161505 Advocacy group Public Citizen files a petition urging FDA to ban prescription drug direct-to-consumer advertising. Thu, 23 Jul 2026 07:40:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161505 http://fdaweb.com/login.php?sa=v&aid=D5161504 Lilly says its triple hormone receptor agonist retatrutide met the primary weight loss endpoint in two Phase 3 trials. Thu, 23 Jul 2026 07:02:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161504 http://fdaweb.com/login.php?sa=v&aid=D5161503 FDA publishes a strategy document on facilitating chemistry, manufacturing, and controls readiness for products in accelerated development, completing its PDUFA 7 commitments in this area. Thu, 23 Jul 2026 05:54:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161503 http://fdaweb.com/login.php?sa=v&aid=D5161502 FDA names Dexcom as the first participant in its new Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot. Wed, 22 Jul 2026 14:10:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161502 http://fdaweb.com/login.php?sa=v&aid=D5161501 FDA approves GSK's Jideytro (zidesamtinib) for certain adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer. Wed, 22 Jul 2026 11:51:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161501 http://fdaweb.com/login.php?sa=v&aid=D5161500 FDA acting commissioner Kyle Diamantas uses a Fox News editorial to tout agency steps he says are providing new jobs for American workers and protecting the nation’s medicine supply. Wed, 22 Jul 2026 11:26:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161500 http://fdaweb.com/login.php?sa=v&aid=D5161499 An analysis by PharmaVoice says FDA could remain without a Senate-confirmed commissioner for months as political and procedural hurdles complicate efforts to fill the agency's top post. Wed, 22 Jul 2026 10:49:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161499 http://fdaweb.com/login.php?sa=v&aid=D5161498 Attorney Jake Leys says MDUFA 6 reauthorization has moved from negotiations into writing the commitment letter that spells out all that FDA and the medical device industry have agreed to. Wed, 22 Jul 2026 10:19:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161498 http://fdaweb.com/login.php?sa=v&aid=D5161497 A citizen petition urges FDA to establish a regulatory framework for implantable brain-computer interfaces designed to expand human sensory perception beyond the natural limits of human vision. Wed, 22 Jul 2026 09:24:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161497 http://fdaweb.com/login.php?sa=v&aid=D5161496 Two Sheppard attorneys say an FDA proposal to require complete safety and risk information within the content of direct-to-consumer radio and TV ads would receive significant pushback and would change the advertising landscape if finalized. Wed, 22 Jul 2026 08:47:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161496 http://fdaweb.com/login.php?sa=v&aid=D5161495 FDA investigators cite contract research organization Cliantha Research over data integrity, documentation and clinical research deficiencies following a recent inspection. Wed, 22 Jul 2026 08:24:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161495 http://fdaweb.com/login.php?sa=v&aid=D5161494 The U.S. House of Representatives passes the FDA Modernization Act 3.0 (H.R. 2821), advancing bipartisan legislation intended to accelerate the adoption of non-animal testing methods in drug development and align the agency’s regulations with changes Congress enacted four years ago. Tue, 21 Jul 2026 11:22:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161494 http://fdaweb.com/login.php?sa=v&aid=D5161493 A Cureus Journal of Medical Science open-source editorial calls for a rebuilding of the U.S. scientific infrastructure as the only way to successfully reform FDA. Tue, 21 Jul 2026 11:18:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161493