Drugs
FDA has issued a final guidance encouraging sponsors of oncology clinical trials to broaden eligibility criteria by including more patients with reduced performance status, arguing that less restrictive enrollment could make study populations more representative of patients treated in routine clinical practice. The guidance, “Cancer Clinical Trial Eligibility Criteria: Performance
Drugs
An FDA briefing document released ahead of a 7/29 Cellular, Tissue, and Gene Therapies Advisory Committee meeting reviewing Capricor Therapeutics’ resubmitted deramiocel for treating cardiomyopathy in male patients with Duchenne muscular dystrophy (DMD) says the company’s Phase 3 HOPE-3 study failed to meet its pre-specified primary
Drugs
FDA has issued a final guidance encouraging cancer clinical trial sponsors to adopt more flexible eligibility criteria related to washout periods and concomitant medications, arguing that unnecessarily restrictive requirements can slow patient enrollment and limit the applicability of trial results to real-world populations. The guidance, “Cancer Clinical Trial Eligibility
Drugs
A final FDA guidance is urging sponsors of cancer clinical trials to broaden laboratory value-based eligibility criteria to reduce unnecessary barriers to patient participation while maintaining appropriate safety protections. The agency said overly restrictive laboratory requirements can limit enrollment, reduce trial diversity, and make study results less representative of
Drugs
FDA is announcing an 8/6 educational Webinar to provide stakeholders with additional information about its proposed Expedited Investigational New Drug (IND) Pilot Program, an initiative designed to shorten the time between drug discovery and the start of first-in-human clinical trials. The one-hour webinar (9:00 a.
FDA Policy/General
An FDA advisory committee 7/23 voted to recommend allowing several controversial peptides to be considered for inclusion on the agency's Section 503A Bulks List for pharmacy compounding, setting up a significant policy decision for the agency amid an ongoing debate over the safety and clinical evidence supporting
Drugs
Amgen has submitted to FDA new scientific data and analyses in its bid to prevent the withdrawal of Tavneos (avacopan), arguing that the treatment continues to demonstrate a favorable benefit-risk profile for patients with severe active ANCA-associated vasculitis (AAV), a rare and potentially life-threatening autoimmune disease. The
Drugs
FDA has issued a Complete Response Letter (CRL) to Apiject Systems Corp., declining to approve the company's NDA for a glycopyrrolate solution drug-device combination product, seeking an indication for use in adults as adjunctive therapy for treating peptic ulcers by reducing the amount of acid produced.The
Devices
FDA has issued an early alert warning healthcare providers about a potentially high-risk issue involving certain lots of Boston Scientific's ENROUTE Transcarotid Neuroprotection System (NPS) and ENROUTE Transcarotid Neuroprotection System Plus (NPS Plus), following reports that the arterial sheath tip can separate during use. The agency said
Drugs
FDA has issued a Form 483 to Bausch + Lomb following a 3/12-20 inspection of the company's sterile drug manufacturing facility in Tampa, FL, identifying multiple observations involving complaint investigations, aseptic manufacturing practices, environmental monitoring, and quality system controls. One observation focused on complaint handling. FDA investigators
Drugs
FDA has published a strategy document on facilitating Chemistry, Manufacturing, and Controls (CMC) readiness for products with accelerated clinical development. The document says its publication completes the four CMC items the agency agreed to do under PDUFA 7. The strategy document says FDA: * published a CDER Manual of Policies and
Drugs
Bringing the keynote address at the Society of Cardiovascular Computed Tomography’s annual meeting, former FDA commissioner Rob Califf warned that efforts need to be made if the nation’s overall population health outcomes are to improve. He said the U.S. faces a troubling paradox in which revolutionary advances
Drugs
The Senate HELP Committee has voted unanimously to advance legislation sponsored by Sen. Rand Paul (R-KY) to streamline the biosimilar approval process. A statement issued by Paul says the Expedited Access to Biosimilars Act would increase market competition, lower drug prices, and increase access to more life-saving treatments.
Drugs
FDA has cited 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 the company's Saint-Benoît, France, facility. According to a just-posted three-page Form FDA 483, investigators documented four inspectional
Biologics
Johnson & Johnson is reporting positive topline results from the three-arm investigational Phase 3 MonumenTAL-6 study evaluating Tecvayli (teclistamab-cqyv) plus Talvey (talquetamab-tgvs), a BCMA and GPRC5D dual antigen targeting regimen, and Talvey plus pomalidomide in adult patients with relapsed or refractory multiple myeloma (RRMM) who received
Drugs
Lilly says its investigational first-in-class GIP, GLP-1, and glucagon triple hormone receptor agonist retatrutide met its primary endpoint in the Class 3 TRIUMPH-2 and TRIUMPH-3 studies, delivering substantial weight loss in adults with obesity complicated by type 2 diabetes and established cardiovascular disease. The company
Drugs
Advocacy group Public Citizen has filed a petition urging FDA to ban prescription drug direct-to-consumer (DTC) advertising. Such a prohibition would “align U.S. policy with international best practices, protect the public from misleading and harmful drug promotion, and promote rational, evidence-based prescribing,” the group contends. “DTC
Drugs
FDA has accepted for review Revolution Medicines' NDA for daraxonrasib, an investigational oral RAS-targeted therapy for patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), the company announced Wednesday. The submission seeks approval of daraxonrasib for adults with metastatic PDAC who have previously received treatment. The drug is
Drugs
Attorney Megan Robertson (Epstein Becker Green) says the biggest trend in FDA Warning Letters so far this year has been the agency’s crackdown against online telehealth platforms that offer compounded GLP-1 drugs. Appearing in a brief video, Robertson says FDA’s push is for the companies to clean
Drugs
FDA has released the form FDA-483 issued following a 2/9-2/18 inspection at the CSL Behring GmbH licensed biological drug manufacturing facility in Marburg, Hassia, Germany. The four inspection observations were: * failure of the quality control unit to review and approve changes to written procedures; * failure to
Drugs
FDA investigators cited Cliantha Research Ltd, a contract research organization in Ahmedabad, India, over data integrity, documentation and clinical research deficiencies following an inspection conducted 4/13-17. The agency issued a four-page Form FDA 483 to the company documenting six inspectional observations at Cliantha's bioanalytical and
Devices
A new citizen petition is urging FDA to establish a regulatory framework for implantable brain-computer interfaces (BCIs) designed to expand human sensory perception beyond the natural limits of human vision. The just-posted petition, filed by Ali Afshar of Age Reversal Unity in New York, asks FDA to develop