Devices
A 7/18-8/1/2025 FDA inspection at ASP Global, doing business as Anatomy Supply Partners in Austell, GA, found multiple violations in the firm’s manufacturing of the Safe-T-Fill Micro Capillary Collection System. A just-released 12/9/2025 Warning Letter cited these specific Quality System
Drugs
Taxpayers Protection Alliance executive director Ross Marchand uses a Baltimore Sun op-ed column to complain that FDA “has lost its way and shuns innovation.” He writes that as a result, “frustrated Americans are increasingly rebelling against the sclerotic agency by turning to gray and black markets for unproven ‘Chinese
Drugs
A 7/14-8/5/2025 FDA inspection at the Winder Laboratories drug manufacturing facility in Winder, GA, found repeat significant violations of current good manufacturing practice (CGMP) regulations. A 1/7 Warning Letter says the specific violations were: * failure to clean, maintain, and, as appropriate for the nature of
Biologics
FDA has accepted for priority review an Argenx supplemental BLA seeking to expand the use of its myasthenia gravis drug Vyvgart (efgartigimod alfa-fcab) to adults with acetylcholine receptor antibody–negative generalized myasthenia gravis. The agency set a user fee review action target date of 5/10. If approved, the
Drugs
At the end of 2025, FDA removed from its Web site an informational page warning parents about the dangers of bogus autism treatments. An online Ars Technica post says elimination of the page was confirmed by HHS, which said it had been retired as part of a routine cleanup of
Drugs
The National Security Commission on Emerging Biotechnology (NSCEB) says FDA’s oversight of medical products through CBER, CDER, and CDRH “has largely been successful for traditional products but is increasingly inefficient when applied to innovative medical products.” In a report, “Modernizing Medical Biotechnology Regulation,” NSCEB says FDA regulatory frameworks were
Biologics
FDA has accepted for review a PharmaEssentia supplemental BLA seeking to expand the label of its interferon therapy Besremi (ropeginterferon alfa-2b-njft) to include adults with essential thrombocythemia. The agency has set a user fee review action target date of 8/30. If approved, the expanded indication would allow
FDA Policy/General
Former FDA Oncology Center for Excellence director Richard Pazdur is warning that political interference and internal upheaval are eroding the agency’s ability to function as a science-driven organization, according to public remarks delivered at a biotech industry gathering in San Francisco. He said the traditional firewall between scientific
Drugs
FDA has extended by three months its review of a Travere Therapeutics supplemental NDA for Filspari in focal segmental glomerulosclerosis (FSGS), pushing the user fee review target action date to 4/13. The extension was prompted after the agency determined that recently submitted responses from Travere to FDA information requests
Drugs
FDA has issued an untitled letter to BeOne Medicines USA, finding that its direct-to-consumer television advertisement for cancer drug Brukinsa (zanubrutinib) was false or misleading. In the letter, CDER’s Office of Prescription Drug Promotion said the broadcast ad for Brukinsa misbranded the drug by creating an inaccurate
Drugs
FDA has classified as Class 1 a recall of certain Sigma Spectrum infusion pumps made by Baxter, warning that continued use of the affected devices could result in serious injury or death. The recall involves removing specific Sigma Spectrum Infusion System platforms from clinical use after Baxter determined that some
Biologics
CBER has released its calendar year 2026 guidance agenda showing it plans to produce 35 draft and final guidances in four categories — Blood and Blood Components (five guidances), Therapeutic Products (19 guidances), Other (two guidances), and Vaccines and Allergenics (nine guidances). In the Vaccines and Allergenics category, CBER says it
Drugs
A 7/28-8/1/2025 FDA inspection at the Chemspec Chemicals Private Limited drug manufacturing facility in Navi Mumbai, Maharashtra, India, found a significant deviation from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A just-released 12/23/2025 Warning Letter says the specific deviation
Drugs
A 1/20-1/24/2025 FDA Bioresearch Monitoring Program inspection at Senthil Specialty Hospital in Pondicherry, Puducherry, India, found that Dr. Purushothaman Kumaran failed to ensure that a clinical in vivo bioequivalence study was conducted according to the investigational plan. A just-released 12/22/2025 Warning Letter says
Drugs
FDA says its evaluation did not find an increased risk of suicidal ideation or behavior in patients using glucagon-like peptide-1 (GLP-1) receptor agonist medications and thus companies should remove statements on suicidal ideation or behavior from the labeling. An agency statement says the affected products are Novo
Biologics
FDA has issued Pierre Fabre Pharmaceuticals a second Complete Response Letter rejecting its BLA for Atara Biotherapeutics’ investigational cell therapy for a rare and often fatal post-transplant cancer, citing the need for additional clinical evidence. The rejection appears to be one of the first rejections under a new CBER
Drugs
A new analysis published in JAMA finds that FDA’s regulation of mifepristone has been driven largely by scientific evidence and internal expert judgment, with limited documented political interference over more than a decade of oversight. The study, released 1/12, examines more than 5,200 pages of internal FDA
Drugs
FDA has accepted for review an EMD Serono NDA for pimicotinib, a potential first-in-class systemic treatment for tenosynovial giant cell tumor (TGCT). The submission is based on data from the global Phase 3 MANEUVER study, which showed statistically significant tumor responses and sustained improvements in patient-reported outcomes,
Biologics
FDA says it is formalizing and more broadly communicating a flexible regulatory approach to chemistry, manufacturing and controls for cell and gene therapies, a move the agency says is intended to speed development of innovative treatments while maintaining product quality standards. An FDA notice says details are being shared on
Drugs
FDA has granted Novita Pharmaceuticals an orphan drug designation for its experimental cancer drug NP-G2-044. Novita says the designation covers the use of NP-G2-044 in pancreatic cancer, including in combination with immune checkpoint inhibitor therapies. “This represents an important regulatory milestone for Novita and validates our
Drugs
FDA has approved a Sentynl Therapeutics NDA for Zycubo (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients. Menkes disease is a neurodegenerative disorder caused by a genetic defect that impairs a child’s ability to absorb copper. “The disease is characterized by seizures, failure to
Drugs
FDA has granted Alessa Therapeutics a fast track designation for Enolen, an experimental localized prostate cancer therapy. The designation applies to Enolen’s use in patients with low to intermediate risk, localized prostate cancer, a population for whom treatment options are often limited to active surveillance or more aggressive interventions