Drugs
An unannounced 7/14-7/18/2025 FDA inspection at the Patcos Cosmetics Pvt. Ltd. drug manufacturing facility in Dadra and Hagar Haveli and Daman, India, found adulterated over-the-counter drug products that have been prepared, packed, or held under insanitary conditions, and had significant violations of current good
Drugs
FDA has issued a draft guidance encouraging drug developers to adopt new approach methodologies (NAMs) as part of a broader effort to reduce reliance on animal testing and improve the prediction of human drug safety. The document outlines a framework for validating these emerging tools, ranging from advanced cell-based
Drugs
FDA has approved Johnson & Johnson’s Icotyde (icotrokinra) to treat moderate-to-severe plaque psoriasis in adults and some pediatric patients aged 12 and older who are candidates for systemic therapy or phototherapy. A company statement says Icotyde is the only targeted oral peptide that precisely blocks the IL-
Drugs
A 9/11-9/26/2025 FDA inspection at the Oralabs drug manufacturing facility in Parker, CO, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs in the company’s work as a contract drug manufacturer. A 3/11 Warning Letter says the specific violations were:
Drugs
A 9/8-9/12/2025 FDA inspection at the Flowchem Pharma Private Limited drug manufacturing facility in Hindupur Taluk, Andhra Pradesh, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 3/11 Warning Letter says the specific deviations were: * failure to
Drugs
BioMarin says it is discontinuing dosing and enrollment in portions of its mid-stage clinical program for Voxzogo (vosoritide) after reports of a rare orthopedic complication emerged in external studies, marking a setback to expand the drug beyond its approved use. In 2021, FDA approved Voxzogo to improve growth in
Drugs
FDA has identified multiple manufacturing and laboratory control deficiencies at Alps Pharmaceutical, following an inspection of the company’s facility in Hida City, Japan, according to an FDA Form 483. The inspection, conducted in October, targeted the firm’s active pharmaceutical ingredient (API) operations and documented lapses in quality control
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it commends FDA for issuing a draft guidance, Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products, to facilitate the advancement and use of complex adaptive, Bayesian, and other novel clinical trial designs. In a comment letter, PhRMA says
FDA Policy/General
Attorneys Nathan Brown and Maddy Bolger (Akin) say regulated industries should assess and incorporate the FDA suggestions in a 3/9 draft guidance, Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection, into their form FDA-483 response practices and, in particular, their corrective and
Drugs
FDA has issued Aldeyra a complete response letter (CRL) for its investigational dry eye treatment reproxalap, concluding that the company failed to provide sufficient evidence the drug is effective. The action is the third CRL issued during its regulatory history, and it follows a three-month review extension by the
Drugs
FDA has extended by three months its review of a Lantheus Holdings’ NDA for LNTH-2501, a diagnostic imaging agent targeting neuroendocrine tumors, pushing the decision date to 6/29. The review extension will allow the agency additional time to evaluate new manufacturing-related information submitted by the company. Lantheus
Drugs
FDA inspectors have cited multiple manufacturing and quality control deficiencies at a sterile drug production facility operated by Gland Chemicals Private Limited in Chennai, India, according to an inspection report issued to the company. The observations were documented in a Form 483 issued following an FDA inspection conducted from in
Drugs
NRx Pharmaceuticals says it has received meeting minutes from a recent Type C guidance meeting with FDA indicating it is willing to review a potential NDA for its investigational therapy NRX-100, a preservative-free intravenous formulation of ketamine, without requiring additional clinical trials. According to the company, the meeting
Drugs
FDA has told NovaBridge Biosciences that its investigational cancer therapy givastomig could be eligible for an accelerated approval pathway following a recent Type B regulatory meeting. The company says written minutes from the meeting confirmed the agency’s willingness to consider accelerated approval for the drug in first-line treatment
Drugs
FDA has accepted for review a Sun Pharmaceutical Industries supplemental BLA seeking to expand the use of Ilumya (tildrakizumab-asmn) to treat adults with active psoriatic arthritis. If approved, the new indication would extend the use of the IL-23 inhibitor beyond its current authorization for moderate-to-severe plaque
Drugs
Telix Pharmaceuticals has resubmitted an NDA seeking approval of its investigational PET imaging agent Pixclara (TLX101-Px, also known as 18F-FET) for evaluating recurrent or progressive glioma. The company says the resubmission includes additional data and statistical analyses requested by the agency after it issued a complete response letter
Drugs
Questions are emerging about the long-term impact of the Commissioner’s National Priority Voucher (CNPV) program, with some policy experts warning the program could expose the agency’s approval process to legal challenges and regulatory uncertainty. The initiative, launched last June by FDA commissioner Marty Makary, offers selected drug
Drugs
FDA has approved Novartis’ Cosentyx (secukinumab) for treating adolescents aged 12 and older with moderate to severe Hidradenitis Suppurativa, expanding the drug’s use into another pediatric indication. The decision makes Cosentyx the only interleukin-17A inhibitor approved in the U.S. for adolescents with the painful inflammatory skin disorder
Drugs
Eli Lilly has issued a “public warning” about potential safety risks associated with compounded tirzepatide (Mounjaro and Zepbound) with vitamin B12. A company statement says Lilly tested compounded products being marketed to Americans that contain tirzepatide combined with B12, sometimes referred to as methylcobalamin, hydroxcobalamin, or cyanocobalamin. It says the
Drugs
BridgeBio Pharma says its investigational therapy BBP-418 showed consistent clinical benefit and a favorable safety profile in an interim analysis of the Phase 3 FORTIFY trial in patients with limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9), a rare and progressive genetic muscle disorder with no approved treatments.
Drugs
A 3/2026 FDA draft guidance, New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers, outlines the agency’s approach to determining new clinical investigation exclusivity. In an online post, attorneys Aziz Burgy and Aaron Savit (Axinn) say the draft guidance also suggests some strategies for
Drugs
Academic researchers say FDA should continue modernizing its foreign inspection framework, ensuring that high-import-volume mutual recognition agreement countries such as Ireland receive scrutiny proportional to their market share, and developing additional metrics to assess whether the unannounced inspection mandate translates into measurable improvements in oversight rigor. Writing in