Drugs
Valisure has sued the United States Pharmacopeia (USP), accusing the standards-setting organization of making false and misleading statements about the laboratory's methods for detecting potentially harmful impurities in medicines. The lawsuit centers on a 2023 USP white paper titled Unvalidated Methods for Medicine Quality Testing Can Lead
Drugs
FDA has issued a draft revised guidance intended to help drug developers determine whether a proposed product should be submitted through the ANDA pathway under Section 505(j) of the Federal Food, Drug, and Cosmetic Act or through the 505(b)(2) NDA pathway. The document, Determining Whether to Submit
Drugs
As Amgen continues its bid to prevent the withdrawal of Tavneos (avacopan) in the U.S., European regulators have recommended the revocation of the drug’s marketing authorization, according to a document outlining concerns. Last month, Amgen submitted to FDA new scientific data and analyses as part of its formal
Drugs
Regeneron Pharmaceuticals has stopped a Phase 1/2a clinical trial of experimental anti-CD3 monoclonal antibody REGN7041 in patients with noninfectious uveitis after a safety event prompted the company to reassess the drug's risk-benefit profile, according to a clinicaltrials.gov posting. Regeneron said the decision to terminate
Biologics
Two Republican senators have released a 5/2021 email from then-acting FDA commissioner Janet Woodcock in which she raised concerns about reports of unexplained adverse events that appeared following Covid-19 vaccination and urged federal health officials to consider conducting a study. Sens. Ron Johnson (R-WI) and Rand
Drugs
FDA is announcing a 9/9 meeting with the Reagan-Udall Foundation for the FDA to hear public comments on perspectives involving opioid medication use for managing pain and addiction. The meeting will also feature a panel discussion with federal partners to discuss efforts to improve the pain management and
Devices
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
Drugs
FDA has approved 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. The approval covers use of the imaging agent, also known as MK-6240, for brain positron emission tomography
Drugs
FDA has granted 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. OS Therapies says an interim three-year overall
Drugs
Last week’s accelerated approval of Replimune’s Tudriqev (vusolimogene oderparepvec-wtpg) came despite significant concerns about the reliability of efficacy results from the company’s Phase 1/2 IGNYTE trial. The genetically modified oncolytic viral therapy’s approval covers its use in combination with Bristol Myers Squibb's
Drugs
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
Biologics
Capricor Therapeutics says it 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 based on its Phase 3 trial’s primary endpoint. FDA has indicated it is willing to review an
Drugs
FDA has granted Bristol-Myers Squibb accelerated approval for Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. Approval was based on data from EXCALIBER-
Devices
On behalf of FDA, the Justice Department has asked the Nevada federal court to issue an injunction to stop Steiner Biotechnology from manufacturing and selling adulterated and misbranded dental products. A department media statement says FDA inspected the Steiner manufacturing facility at least four times from 2018 to 2025, finding
Drugs
ADC Therapeutics says that at a recent meeting with FDA, agency officials indicated that they have “substantial concerns regarding the benefit/risk or verification of clinical benefit” in the LOTIS-5 trial of the company’s Zynlonta (loncastuximab tesirine) to treat diffuse large B-cell lymphoma (DLBCL). In an online
Drugs
FDA has released the Form FDA-483 with three observations from a 2/19-2/27 inspection at the Reliance Life Sciences Private Limited drug manufacturing facility in Navi Mumbai, Maharashtra, India. The observations were: * failure of laboratory records to include complete data derived from all tests, examinations, and assay
Drugs
FDA has released proposed recommendations for the eighth reauthorization of the Prescription Drug User Fee Act (PDUFA VIII), outlining changes to drug review, manufacturing oversight, regulatory science programs and the structure of industry fees for fiscal years 2028 through 2032. The proposed PDUFA VIII commitment letter follows negotiations with the
Drugs
FDA has issued a draft guidance proposing a risk-based framework for evaluating the container-closure systems used to package human drugs and biologics. The draft, “Container Closure Systems for Human Drugs and Biological Products,” covers packaging systems for drugs, biologics and combination products and addresses the quality assessment and
Drugs
New real-world reports of edema and other serious heart and respiratory problems among people with Prader-Willi syndrome (PWS) taking Neurocrine’s Vykat XR have prompted PWS patient groups to issue recommendations for closer monitoring of some patients, according to the Foundation for Prader-Willi Research. FDA is “evaluating
Drugs
In a 64-page petition, Children’s Health Defense calls on FDA to withdraw over-the-counter approval for Infants’ Tylenol and other products containing acetaminophen approved for use with children under age two. The petition also asks the agency to require a Boxed Warning and other safety information concerning
Drugs
FDA should strengthen advisory committee deliberations by appointing more temporary voting members, according to Center for Medicine in the Public Interest president Peter Pitts and vice president Robert Goldberg. Writing in a Real Clear Health opinion column, Pitts and Goldberg say the agency already has the authority to appoint temporary
Drugs
While U.S. biotech companies focused on treating rare and serious diseases overwhelmingly prefer to conduct first-in-human (FIH) clinical trials in the U.S., historical obstacles posed by FDA are prompting the companies to seek development overseas. That’s a key finding from a survey of 37 U.