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
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,
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
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
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) has issued BeOne Medicines USA an untitled letter over its promotional materials for cancer immunotherapy Tevimbra (tislelizumab-jsgr), citing omissions of risk information and an overly broad portrayal of the drug’s approved uses. FDA says said it reviewed two branded Microsoft
Drugs
Representatives of FDA and the drug industry made progress on PDUFA 8 negotiations on real-world evidence (RWE) and first-cycle reviews at the 12/9/2025 FDA/Industry Premarket Subgroup session. According to the meeting minutes, on real-world evidence FDA recommended that the pilot be continued in PDUFA
Biologics
With all the staffing turmoil FDA went through in 2025, drug and biologic approvals dropped below totals in the previous two years. A Fierce Pharma analysis finds that there were 46 novel drug approvals in 2025, compared to 55 in 2023 and 50 in 2024. In addition, there were 18
Drugs
GSK says its investigational bepirovirsen met the primary endpoints in the B-Well 1 and B-Well 2 pivotal Phase 3 trials evaluating it as a treatment for chronic hepatitis B in over 1,800 patients. A company statement says GSK plans global regulatory filings from the first quarter of
Drugs
FDA has notified Vanda Pharmaceuticals that its sNDA for Hetlioz (tasimelteon) to treat jet lag disorder cannot be approved in its present form. A company statement says the agency acknowledged positive efficacy from the company’s clinical trials, but said the data do not provide substantial evidence of efficacy for
Drugs
Moonlake Immunotherapeutics says it plans to submit a BLA to FDA in the second half of 2026 for sonelokimab to treat hidradenitis suppurativa. A company statement says the decision to move forward followed a successful Type B meeting with FDA that confirmed that the company may establish substantial evidence of
Drugs
In a significant policy shift aimed at modernizing federal oversight of digital health technologies, FDA commissioner Marty Makary is promoting limited regulatory scrutiny of many wearable devices and software tools, especially those that provide general wellness information rather than medical diagnoses or treatment guidance. The move, outlined by Makary’s
Drugs
FDA says the Abiomed 6/23/2025 correction updating the use instructions for its Automated Impella Controllers is Class 1. An agency statement says the company informed affected customers that an Automated Impella Controller may not detect an Impella pump when connected. Abiomed recommended having a backup Automated Impella Controller
Drugs
FDA says its review of the Web site and social media accounts maintained by Agebox, Inc., in Wilmington, DE, determined that it offered iKids-Growth products for sale in the U.S. A 12/19/2025 Warning Letter says FDA obtained samples of the iKids-Growth products and determined that
Drugs
A 4/22-4/24/2025 FDA inspection at the Absolutely Natural drug manufacturing facility in Melbourne, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 12/30/2025 Warning Letter says the specific violations were: * failure to thoroughly investigate any unexplained discrepancy or