FDA Webview The leading publisher of FDA News, FDA Review, FDA Compliance, QSR News, and Food Drug Administration information since 1984. http://fdaweb.com/ Sun, 16 Aug 2026 06:27:40 -0500 FDA Warns Aurobindo Pharma’s Eugia Unit http://fdaweb.com/login.php?sa=v&aid=D5161631 FDA has issued a warning letter to a Telangana, India, sterile drug manufacturing facility operated by Aurobindo Pharma subsidiary Eugia Pharma Specialities, following a February inspection (see earlier story) that identified deficiencies involving aseptic manufacturing, process validation, visual inspection and investigations of complaints involving glass particles. The agency subsequently classified the facility as Official Action Indicated Fri, 14 Aug 2026 14:01:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161631 FDA OKs Lantheus’ Tau PET Imaging Agent for Alzheimer’s Disease http://fdaweb.com/login.php?sa=v&aid=D5161630 FDA approves Lantheus Holdings’ Tauklarify (florquinitau F 18 injection) as a PET imaging agent to identify tau neurofibrillary tangle pathology in adults with cognitive impairment being evaluated for Alzheimer’s disease. Fri, 14 Aug 2026 12:45:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161630 Replimune Approval Document Highlights Reviewer Objections http://fdaweb.com/login.php?sa=v&aid=D5161629 An FDA approval document shows that the accelerated approval of Replimune’s Tudriqev came despite significant concerns about the reliability of efficacy results from the company’s Phase 1/2 IGNYTE trial. Fri, 14 Aug 2026 12:29:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161629 Baxter Recalls Duo-Vent Solution Sets Over Air Embolism Risk http://fdaweb.com/login.php?sa=v&aid=D5161628 Baxter is recalling (Class 1) certain lots of its Duo-Vent solution sets because the devices may allow air bubbles to enter the administration set during pressure infusion or flushing, potentially exposing patients to serious injury or death. The issue involves the potential formation of air bubbles in the drip chamber and tubing when a pressure cuff is being used or when the tubing is flushed with the line in the fully open position, according Fri, 14 Aug 2026 09:33:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161628 FDA Meeting to Review Survival Data for Osteosarcoma Therapy http://fdaweb.com/login.php?sa=v&aid=D5161627 FDA grants OS Therapies a Type C statistical methods meeting with CBER to discuss 2.5-year overall survival data for OST-HER2, the company’s investigational immunotherapy for preventing or delaying recurrence in patients with fully resected, pulmonary metastatic osteosarcoma. Fri, 14 Aug 2026 08:15:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161627 Capricor Plans Deramiocel BLA Amendment After FDA Input http://fdaweb.com/login.php?sa=v&aid=D5161626 Capricor Therapeutics plans to amend its BLA for deramiocel to modify its proposed indication after discussions with FDA produced a potential path toward approval of the Duchenne muscular dystrophy therapy. Fri, 14 Aug 2026 07:32:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161626 Accelerated Approval for Zenbexus Combo in Multiple Myeloma http://fdaweb.com/login.php?sa=v&aid=D5161625 FDA grants Bristol-Myers Squibb accelerated approval for Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma. Thu, 13 Aug 2026 11:39:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161625 Experts Warn of Edema Risk With Vykat XR as FDA Evaluates Risk http://fdaweb.com/login.php?sa=v&aid=D5161624 Foundation for Prader-Willi Research warns that real-world reports of edema and other serious heart and respiratory problems among patients taking Neurocrine’s Vykat XR have prompted recommendations for closer monitoring of some patients. Thu, 13 Aug 2026 11:21:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161624 Guidance on Risk-Based Approach to Drug Packaging Systems http://fdaweb.com/login.php?sa=v&aid=D5161623 FDA issues a draft guidance proposing a risk-based framework for evaluating the container-closure systems used to package human drugs and biologics. Thu, 13 Aug 2026 11:19:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161623 PDUFA VIII Commitment Letter Outlines Changes to Drug Review, Manufacturing Oversight http://fdaweb.com/login.php?sa=v&aid=D5161622 FDA releases the proposed recommendations for the eighth reauthorization of the Prescription Drug User Fee Act, outlining changes to drug review, manufacturing oversight, regulatory science programs and the structure of industry fees. Thu, 13 Aug 2026 11:14:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161622 3 Observations on Reliance Life Sciences FDA-483 http://fdaweb.com/login.php?sa=v&aid=D5161621 FDA releases the Form FDA-483 issued following an inspection at India’s Reliance Life Sciences drug manufacturing facility in Navi Mumbai. Thu, 13 Aug 2026 09:16:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161621 FDA Questions Zynlonta’s Benefit/Risk: Report http://fdaweb.com/login.php?sa=v&aid=D5161620 FDA is raising questions about the risk/benefit of ADC Therapeutics’ Zynlonta as a second-line treatment for diffuse large B-cell lymphoma. Thu, 13 Aug 2026 09:02:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161620 FDA Seeks Injunction Against Steiner Biotechnology http://fdaweb.com/login.php?sa=v&aid=D5161619 The Department of Justice seeks an injunction to stop Steiner Biotechnology from manufacturing and marketing adulterated and misbranded dental medical devices that have been subject to FDA warnings for seven years. Thu, 13 Aug 2026 06:59:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161619 FDA Guide Updates Procedures for Formal Drug/Biologic Meetings http://fdaweb.com/login.php?sa=v&aid=D5161618 FDA posts an updated guidance outlining procedures for formal meetings between the agency and sponsors or applicants developing or seeking approval for drugs and biological products. Wed, 12 Aug 2026 11:31:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161618 Theresa Mullin Retires as CDER Associate Director http://fdaweb.com/login.php?sa=v&aid=D5161617 CDER associate Center director for strategic initiatives Theresa Mullin retires after 28 years at the agency. Wed, 12 Aug 2026 11:28:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161617 Lilly Files Six Lawsuits Over Illegal Retatrutide Sales http://fdaweb.com/login.php?sa=v&aid=D5161616 Eli Lilly files six new lawsuits against U.S. entities it alleges are selling illegal, unapproved retatrutide products. Wed, 12 Aug 2026 11:24:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161616 FDA Obstacles Lead to Overseas Trials: Survey http://fdaweb.com/login.php?sa=v&aid=D5161615 A survey of 37 biotech executives shows FDA obstacles are sending more first-in-human trials overseas. Wed, 12 Aug 2026 11:00:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161615 Use More Advisory Committee Temporary Voting Members: Column http://fdaweb.com/login.php?sa=v&aid=D5161614 A Center for Medicine in the Public Interest opinion column calls on FDA to more aggressively recruit and use advisory committee temporary voting members. Wed, 12 Aug 2026 10:50:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161614 Ban Infants’ Tylenol: Children’s Health Defense http://fdaweb.com/login.php?sa=v&aid=D5161613 Children’s Health Defense petitions FDA to ban Infants’ Tylenol and place Boxed Warnings on labeling for some other Tylenol products. Wed, 12 Aug 2026 10:02:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161613 FDA Expedited IND to Lean on Rolling Submissions/Reviews http://fdaweb.com/login.php?sa=v&aid=D5161612 FDA officials detailing the agency’s new expedited IND pilot program say a central feature will be a rolling pre-IND submission process. Wed, 12 Aug 2026 09:55:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161612