Drugs
With FDA using its artificial intelligence (AI) tool ELSA during inspections, regulated companies can better prepare for inspections by using their own AI tool. That’s the view of former FDAer David Elder. Writing in a Med Device Online guest column, Elder says using ELSA enables an FDA investigator to
Drugs
FDA has released the form FDA-483 with three observations from a 4/20-5/04 inspection at the QuVa Pharma outsourcing facility in Sugar Land, TX. The specific inspection observations were: * failure to establish and follow written procedures to prevent microbiological contamination of drug products purporting to be sterile;
Drugs
FDA has granted Vera Therapeutics an accelerated approval for Trutakna (atacicept-vymj) to reduce proteinuria in adults with primary immunoglobulin A (IgA) nephropathy who are at risk of disease progression, providing a new treatment option for patients with the chronic kidney disease. The once-weekly subcutaneous injection’s approval was
Drugs
Saol Therapeutics has resubmitted its NDA for SL1009 (sodium dichloroacetate, or DCA), an investigational treatment for pyruvate dehydrogenase complex deficiency (PDCD), a rare and life-threatening mitochondrial disorder with no currently approved therapies. The resubmission follows additional analyses requested by FDA after the agency issued a Complete Response Letter (CRL)
Drugs
The HHS Inspector General (IG) has issued an advisory opinion that favorably addressed a drug manufacturer’s program to provide free antibody testing to determine whether it would be appropriate to prescribe the manufacturer’s product. Attorneys Dominick DiSabatino and Audrey Mercer (Sheppard) write in an online post on their
Drugs
A 1/12-1/22 FDA inspection at the Excelvision – Fareva drug manufacturing facility in Annonay, France, found repeat significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/25 Warning Letter says the specific violations were: * failure to thoroughly investigate any unexpected discrepancy or failure
Drugs
A 1/12-1/20 FDA inspection at the Genzyme Ireland facility located in County Wexford, Ireland, documented significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/22 Warning Letter says the specific violation was the failure of the firm’s quality control unit to
Drugs
FDA has selected seven companies to participate in the FDA PreCheck Pilot Program, an initiative it says is intended to boost American global competitiveness, strengthen domestic drug manufacturing, and improve the resilience of the U.S. drug supply chain. An agency statement says the pilot was launched 2/1 in
Drugs
FDA has published a guidance, Submitting Next-Generation Sequencing Data to the Division of Antivirals, with the agency’s current thinking about the submission of next-generation sequencing (NGS) protocols, data, and analysis supporting resistance assessments for developing antiviral drugs. The document says the provision of comprehensive and accurate resistance
Drugs
FDA has approved Orca Biosystems’ Tregzi (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq) suspension, for intravenous infusion, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adults with blood cancers undergoing allogeneic hematopoietic stem cell transplantation.
Drugs
A 12/3-12/10/2025 FDA inspection at the Wizcure Pharmaa Private Limited drug manufacturing facility in Rajasthan, India, fund significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/24 Warning Letter says the specific violations were: * failure to ensure that laboratory records included
Drugs
FDA says the Yangzhou Hongshengding Chemical Co. in Guangling District, Yangzhou, China, is registered with FDA as a manufacturer of over-the-counter drug products and did not respond to several requests for records and other information relating to its operations. A just-released 6/15 Warning Letter says the
Biologics
CBER has published a Standard Operating Policy and Procedure (SOPP) to guide staff in implementing and maintaining Risk Evaluation and Mitigation Strategies (REMS). The document says the SOPP applies to an initial REMS as part of an original BLA or NDA, or a new REMS needed as part of an
Drugs
FDA approved 23 novel drugs during the first six months of 2026, maintaining a pace that would be consistent with recent years despite an unusually turbulent period marked by leadership turnover, high-profile regulatory disputes and policy changes under the Trump administration. According to FDA's novel drug approvals
Drugs
FDA has issued Ascelia Pharma a Complete Response Letter regarding its NDA for Orviglance, a contrast agent for liver imaging. The company says the letter is requesting additional clinical data and product documentation. “We seek to understand the issues in detail and plan to request a Type A meeting with
Drugs
FDA has approved a supplemental indication for Vertex Pharmaceuticals’ Casgevy (exagamglogene autotemcel) for patients aged 2 and older with either sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) or transfusion-dependent β thalassemia (TDT). An agency notice says it’s the first gene therapy approved for patients aged
Drugs
FDA has approved PharmaEssentia’s BESREMi Pen (ropeginterferon alfa-2b-njft) for polycythemia vera (PV). A company statement says PharmaEssentia plans to submit a sBLA to FDA seeking a broader indication to include essential thrombocythemia. FDA previously granted an orphan drug designation for BESREMi to treat PV in adults.
Drugs
A new analysis of FDA inspection data suggests pharmaceutical manufacturing facilities in the U.S. received a higher proportion of the agency's most serious inspection classification than Indian plants in 2025, marking a reversal from a decade ago. The analysis, authored by Anil Kumar Angrish of the National
Drugs
FDA has issued Dr. Reddy's Laboratories a seven-observation Form 483 following a recent pre-license inspection of its biologics manufacturing facility in Bachupally, Hyderabad, India. The inspection was conducted from 6/16 to 6/25 as part of FDA's review of the facility ahead of
Drugs
FDA has issued Lantheus a Complete Response Letter (CRL) for its NDA seeking approval for LNTH-2501 (gallium-68 edotreotide), a positron emission tomography (PET) imaging agent for detecting neuroendocrine tumors (NETs). According to the company, the agency letter said it could not approve the application until inspection-related deficiencies
Drugs
FDA has issued Sobi a Complete Response Letter (CRL) on its BLA that is seeking approval of NASP (nanoencapsulated sirolimus plus pegadricase) for treating adults with uncontrolled gout. The letter cited manufacturing-related deficiencies that must be corrected. The company said FDA requested additional information primarily related to the chemistry,
Drugs
FDA has issued an untitled letter to Pinnacle Biologics, alleging that promotional videos for the company's cancer therapy Photofrin (porfimer sodium) contain false and misleading claims that misbrand the product under the Federal Food, Drug, and Cosmetic Act. The CDER Office of Prescription Drug Promotion (OPDP) letter focuses