Drugs
FDA has accepted and granted priority review for an sBLA seeking approval to update the label for Merck’s Winrevair (sotatercept-csrk) based on the Phase 3 ZENITH trial. A company statement says Winrevair was approved in 2024 to treat adults with pulmonary arterial hypertension (PAH) to increase exercise capacity,
Biologics
Former FDA commissioner Scott Gottlieb says that under HHS secretary Robert F. Kennedy, Jr., the change to the membership of the CDC Advisory Committee on Immunization Practices (ACIP) “does look like a political process right now.” Gottlieb commented on the 6/29 CBS News program “Face the Nation.” “I think
Drugs
FDA says Sandoz recalled one lot of Cefazolin for Injection, USP, 1 gram vial, following a customer complaint indicating that four penicillin G potassium for injection, USP, 20 million units labeled vials were incorrectly included in a carton of Cefazolin for Injection. An agency notice says there is a reasonable
Devices
FDA has given 510(k) clearance to Philips’ SmartSpeed Precise dual AI (artificial intelligence) software across the company’s entire portfolio of MRI systems. A company statement says SmartSpeed Precise combines: * compressed SENSE, Philips’ acceleration engine; * an AI-powered denoising engine that enhances image clarity by reducing noise; and * a
Drugs
FDA has published a draft guidance, Myelodysplastic Syndromes: Development of Drug and Biological Products for Treatment, to assist sponsors in the clinical development of products to treat the syndromes. The document contains the agency’s current thinking about the overall development program and clinical trial designs for the development of
Biologics
Moderna says its mRNA-1010 investigational seasonal flu vaccine achieved the most stringent superiority criterion prespecified in a Phase 3 efficacy trial that tested it against a licensed standard-dose influenza vaccine in adults aged 50 and older. A company statement says that in a previous Phase 3 study, the
Drugs
A 6/3-6/11/2024 FDA bioresearch monitoring inspection at a clinical site maintained by Dr. Peter Michael in Hialeah, FL, found that Michael did not adhere to the law and regulations governing the conduct of clinical investigations and protecting human subjects in two studies. A just-released 6/
Drugs
FDA has given accelerated approval to Regeneron’s Lynozyfic (linvoseltamab-gcpt), a bispecific B-cell maturation antigen-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-
Biologics
A 1/28-2/5 FDA inspection at InVia Fertility Specialists in Hoffman Estates, IL, documents significant violations of the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps). A just-released 6/13 Warning Letter says the specific violations were: * failure to test a specimen
Drugs
A 12/13-12/20/2024 FDA inspection at the Healwell Homeo Private Limited drug manufacturing facility in Ahmedabad, Gujarat, India, found the firm’s homeopathic and over-the-counter drug products were adulterated in that they were prepared, packed, or held under insanitary conditions so they may have become
Devices
In an updated safety communication, FDA says Contec has issued a software patch to fix cybersecurity vulnerabilities in certain Contec and Epsimed patient monitors. The agency notice says the patch fully removes networking functionality from the affected monitors, making them usable only for local monitoring. In a 1/30 safety
Drugs
FDA says its review of a Web site maintained by www.buynetmeds.com determined that it is selling misbranded and unapproved new drugs. A just-released 6/12 Warning Letter says the agency observed that the site introduces into interstate commerce unapproved and misbranded opioid drug products. The letter also
Devices
FDA says Baxter has issued a letter to affected customers recommending that certain Spectrum infusion pumps be removed from where they are used or sold. An agency Early Alert said Baxter recommended that customers with the affected pumps remove them from service and check the software version installed on the
Drugs
FDA says it is revising the labeling of all extended-release stimulants intended to treat attention-deficit/hyperactivity disorder (ADHD), including certain formulations of amphetamine and methylphenidate, to warn about the risk of weight loss and other adverse reactions in patients younger than age six taking the medications. An agency
Drugs
FDA has issued a draft guidance entitled Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations. The document is intended to clarify key factors in calculating the aluminum content to ensure that the total aluminum exposure (TAE) from parenteral nutrition (PN) does
FDA Policy/General
The FDA rollout of its generative artificial intelligence (AI) staff tool Elsa is in many ways a “nuanced dance between innovation and responsibility.” That’s the view of ERB Lab Services principal consultant and owner Erika Roberts, based on her more than 15 years of experience working in various areas
Devices
FDA has approved a Sirtex Medical PMA for its SIR-Spheres Y-90 resin microspheres for treating unresectable hepatocellular carcinoma (HCC) in the United States. HCC is the most common form of liver cancer in adults in the U.S., according to the American Cancer Society. Radioembolization with SIR-Spheres
Biologics
A group of medical societies has filed suit against HHS secretary Robert F. Kennedy Jr. and FDA commissioner Marty Makary to reverse a 5/27 decision (see earlier story) to revoke Covid-19 vaccine recommendations for children and pregnant people. The lawsuit was filed in the U.S. District Court
Devices
FDA has cleared an Atmo Biosciences 510(k) for the ingestible Atmo Gas Capsule System for assessing both whole and regional gut transit times — covering the stomach, small bowel, and colon — as an aid in diagnosing gastrointestinal motility disorders (gastroparesis and slow transit constipation). “By measuring regional and whole gut
Drugs
A new FDA report breaks down the demographic representation of clinical trials supporting the approval of 50 novel drug therapies approved in 2024, which involved 31,000 clinical trial participants. The report, which is intended to provide insight into persistent disparities and areas of progress in clinical research, is part
Drugs
In a move to reduce burdens on healthcare providers and improve patient access, FDA is removing risk evaluation and mitigation strategies (REMS) requirements for all currently approved BCMA- and CD19-directed autologous CAR T cell therapies, explaining that the programs are no longer necessary to ensure patient safety. The action
Drugs
UCB is announcing positive data from a Phase 3 clinical trial evaluating fenfluramine as an adjunctive treatment for CDKL5 Deficiency Disorder (CDD). The trial met both its primary and key secondary endpoints in patients with the rare and severe form of epilepsy, according to the company. The primary outcome was