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
Drugs
FDA has cited Aurobindo Pharma USA for multiple failures to comply with federal drug supply chain security requirements, including delays in reporting stolen prescription drugs to the agency, according to a just-posted FDA Form 483. The inspection report was issued following a 2024 inspection and is just now being
Devices
AVID Medical has recalled (Class 1 device correction) certain organ recovery and medical convenience kits, warning that continued use of a non-medical-grade component could lead to serious injury or death. According to an agency notice, AVID Medical identified that 24-by-30-inch poly bags included in certain
Drugs
A new FDA guidance document details how drug developers can appropriately use Bayesian statistical methods in clinical trials intended to support approvals, signaling continued openness to innovative trial designs while emphasizing rigor, transparency, and prespecification. The document, Use of Bayesian Methodology in Clinical Trials of Drugs and Biologics, describes FDA’
Drugs
FDA has told Aquestive Therapeutics that deficiencies have been identified in the company’s NDA for Anaphylm that currently preclude labeling and post-marketing commitments discussions, though the agency emphasized that its review remains ongoing and no final decision has been made. In a regulatory update, the company said FDA
Drugs
FDA has accepted for review a Camurus NDA resubmission for Oclaiz (octreotide), a once-monthly treatment for acromegaly. The agency assigned a 6/10 user fee review action target date. Camurus says it resubmitted the NDA on 12/10 after receiving earlier in the year a complete response letter that