The leading publisher of FDA News, FDA Review, FDA Compliance, QSR News, and Food Drug Administration information since 1984. http://fdaweb.com/ Fri, 17 Jul 2026 21:49:48 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161477 A new study suggests that direct-to-consumer prescription drug Web sites may better communicate the limitations of FDA accelerated approvals when disclosures use consumer-friendly language rather than technical wording drawn from physician labeling. Fri, 17 Jul 2026 10:51:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161477 http://fdaweb.com/login.php?sa=v&aid=D5161476 Bolton Medical recalls its Relay Pro Thoracic Stent Graft Systems due to reports of a deployment failure that may result in serious injury or death. Fri, 17 Jul 2026 10:33:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161476 http://fdaweb.com/login.php?sa=v&aid=D5161475 FDA issues a Form-483 to Charles River Laboratories' Endosafe contract testing laboratory in Charleston, SC, over multiple quality system deficiencies following a March inspection. Fri, 17 Jul 2026 08:29:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161475 http://fdaweb.com/login.php?sa=v&aid=D5161474 FDA accepts for review a Camurus NDA resubmission for Oclaiz (octreotide), a long-acting injection for treating acromegaly. Fri, 17 Jul 2026 07:47:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161474 http://fdaweb.com/login.php?sa=v&aid=D5161473 FDA cites Fujifilm Diosynth Biotechnologies USA for significant manufacturing deficiencies at its drug substance facility in Research Triangle Park, NC. Fri, 17 Jul 2026 06:22:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161473 http://fdaweb.com/login.php?sa=v&aid=D5161472 Kalshi launches a pilot program allowing traders to buy and sell contracts tied to the outcomes of late-stage clinical trials and FDA regulatory decisions. Thu, 16 Jul 2026 11:14:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161472 http://fdaweb.com/login.php?sa=v&aid=D5161471 FDA approves Merck's Lipfendra (enlicitide) 20 mg tablets as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol in certain adults with hypercholesterolemia. Thu, 16 Jul 2026 11:07:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161471 http://fdaweb.com/login.php?sa=v&aid=D5161470 FDA publishes the latest CDER guidance agenda showing plans for 85 new or revised guidances to be issued in 2026. Thu, 16 Jul 2026 10:58:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161470 http://fdaweb.com/login.php?sa=v&aid=D5161469 Rep. Diana DeGette (D-CO) wins FDA assurances that several policy announcements issued during former commissioner Marty Makary's tenure — including articles published in medical journals and media interviews— are not intended to be recognized as official agency guidance. Thu, 16 Jul 2026 10:47:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161469 http://fdaweb.com/login.php?sa=v&aid=D5161468 The American Society of Health System Pharmacists says there were 227 active drug shortages in the second quarter of 2026, trending up for the third quarter in a row. Thu, 16 Jul 2026 10:33:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161468 http://fdaweb.com/login.php?sa=v&aid=D5161467 MassDevice reports a Minnesota federal judge gave significant victories to Medtronic and FDA in four cases involving the company’s spinal cord stimulators. Thu, 16 Jul 2026 10:17:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161467 http://fdaweb.com/login.php?sa=v&aid=D5161466 FDA releases the form FDA-483 with 13 observations from an April inspection at China’s Zhejiang Hushai Pharmaceutical Co. Thu, 16 Jul 2026 08:43:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161466 http://fdaweb.com/login.php?sa=v&aid=D5161465 FDA releases the form FDA-483 with five observations from an inspection at Iceland’s Alvotech EF. Thu, 16 Jul 2026 08:40:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161465 http://fdaweb.com/login.php?sa=v&aid=D5161464 FDA accepts for review an Axsome Therapeutics NDA for AXS-12 (reboxetine) for treating cataplexy in patients with narcolepsy. Wed, 15 Jul 2026 13:37:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161464 http://fdaweb.com/login.php?sa=v&aid=D5161463 FDA grants Roche a priority review for its supplemental BLA seeking approval for Gazyva (obinutuzumab) for treating adults with primary membranous nephropathy. Wed, 15 Jul 2026 11:12:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161463 http://fdaweb.com/login.php?sa=v&aid=D5161462 A Reuters deep dive into HHS secretary Robert F. Kennedy Jr.’s efforts to eliminate childhood vaccine requirements says his aides asked FDA for access to Sentinel and BEST data. Wed, 15 Jul 2026 10:48:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161462 http://fdaweb.com/login.php?sa=v&aid=D5161461 A Cancer Network post says FDA issued a voluntary action indicated close-out letter to HLB following a CGMP inspection at a facility manufacturing the company’s hepatocellular cancer drug. Wed, 15 Jul 2026 10:03:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161461 http://fdaweb.com/login.php?sa=v&aid=D5161460 FDA acting commissioner Kyle Diamantas positions the agency’s four public health pillars as a means to fulfill its enduring mission in a new era. Wed, 15 Jul 2026 09:59:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161460 http://fdaweb.com/login.php?sa=v&aid=D5161459 House Energy and Commerce Health Subcommittee leaders reveal differing views over whether the Trump administration's policies are strengthening or undermining the nation's drug development enterprise. Wed, 15 Jul 2026 09:50:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161459 http://fdaweb.com/login.php?sa=v&aid=D5161458 Witnesses at a House Energy and Commerce Health Subcommittee hearing urge lawmakers to modernize the nation's clinical trial system, and strengthen FDA’s scientific capacity to offset China’s rapidly growing share of early-stage drug development. Wed, 15 Jul 2026 09:47:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161458