Drugs
FDA has issued a Warning Letter to CareFusion, a subsidiary of Becton Dickinson, citing widespread and repeat violations of current good manufacturing practice regulations at a Texas facility that produces sterile drug products. The 4/30 letter follows an FDA inspection at the company’s El Paso manufacturing site conducted
Drugs
An FDA review of records provided by Respilon Production S.R.O., a producer of over-the-counter drugs in Jihomoravsky, Czechia, in response to the agency’s 5 /2/2025 request, found five significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/20 Warning
Drugs
FDA’s accelerated approval pathway, which is more than three decades old, has undergone major changes since 2024 following mounting evidence of systemic weaknesses, including delayed confirmatory trials, questionable validity of surrogate endpoints, and inconsistent enforcement. A Bioprocess Online guest column says the changes started with a 2024 comprehensive draft
Drugs
FDA and TransCelerate are reporting highlights from a recent joint tabletop exercise in which the CDER Center for Clinical Trial Innovation and the nonprofit focused on how to streamline the collection of safety data, which TransCelerate says is an essential step in scaling the use of pragmatic elements in clinical
Drugs
FDA has withdrawn or blocked the publication of multiple internal studies supporting the safety of Covid-19 and shingles vaccines, according to a report by CNBC, a move that is drawing scrutiny in light of the agency’s stated commitment to “radical transparency.” A spokesperson for the U.S. Department
Drugs
A 10/27-10/31/2025 FDA inspection at the Active Cosmetics Manufacturing drug manufacturing facility in Orlando, FL, found three significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/22 Warning Letter says the specific violations were: * failure to thoroughly investigate any unexplained discrepancy
Drugs
FDA has issued an untitled letter to Bayer HealthCare Pharmaceuticals, citing misleading direct-to-consumer advertising for its prostate cancer drug Nubeqa. In the letter, FDA’s Office of Prescription Drug Promotion said a YouTube video and a Spanish-language television advertisement for Nubeqa omit key safety information and fail
Drugs
FDA commissioner Marty Makary is signaling a broad push to overhaul how the agency reviews new drugs, aiming to reduce early-stage regulatory friction, accelerate clinical trials, and expand the use of novel programs designed to shorten approval timelines. In remarks at a 5/4 Milken Institute conference detailing his
Drugs
Clene says it plans to submit an NDA in the third quarter for its experimental amyotrophic lateral sclerosis (ALS) therapy, CNM-Au8, following feedback from FDA that indicated the company’s data could support an accelerated approval. According to the company, FDA officials indicated during a recent Type C meeting
Drugs
The U.S. Supreme Court has temporarily blocked a 5/1 lower court ruling that would have curtailed access to the abortion pill mifepristone, preserving the current FDA regulatory framework while the justices consider emergency appeals. The administrative stay, issued by justice Samuel Alito, halts the U.S. Court of
Drugs
FDA has cited multiple manufacturing and quality control deficiencies at a facility operated by Allergan Pharmaceuticals in Ireland following an inspection last year, according to a just-released agency inspection report. The Form 483 outlines concerns spanning testing procedures, cleaning validation and environmental monitoring in aseptic areas. Among the observations,
Drugs
FDA has authorized an expanded access program for an experimental pancreatic cancer therapy from Revolution Medicines, allowing certain patients to receive the drug outside of clinical trials. The agency said it issued a “safe to proceed” letter enabling the company to launch an expanded access treatment protocol for daraxonrasib, a
Drugs
FDA has approved Arvinas Operations’ Veppanu (vepdegestrant) for treating certain patients with advanced breast cancer, marking the first authorization of a heterobifunctional protein degrader in this setting. The approval action covers adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic
Drugs
FDA has released the form FDA-483 issued following a 2/16-2/27 inspection at Eugia Pharma Specialties Limited, a Telangana, India, sterile pharmaceutical manufacturer. Inspection observations included: * failure to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; * failure of procedures
Drugs
FDA says it has determined that there is no clinical need for outsourcing facilities to use semaglutide, tirzepatide, and liraglutide (the active pharmaceutical ingredients in Novo Nordisk’s and Lilly’s GLP-1 diabetes and weight loss drugs) in compounding. A 5/1 Federal Register notice invites public comment until
Drugs
Five Hogan Lovells attorneys tackle whether and how life sciences companies can use artificial intelligence (AI) tools in their clinical development for medical products and regulatory workflows. In an online post, the attorneys look at two related questions: * whether AI can be used to help interpret or analyze clinical study
Drugs
FDA has approved an expanded use for Axsome Therapeutics’s Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) to treat agitation associated with dementia due to Alzheimer’s disease. The decision broadens the label for the drug, which was originally approved in 2022 for major depressive disorder, and provides a new treatment
Drugs
FDA’s Oncologic Drugs Advisory Committee has voted 6 to 3 against supporting AstraZeneca’s investigational breast cancer therapy camizestrant, dealing a setback to the company’s efforts to bring the oral SERD to market. Camizestrant is being developed for patients with hormone receptor–positive, HER2-negative breast cancer harboring
Drugs
A Clinical Trial Vanguard online post explains the need for a prospective artificial intelligence (AI) versioning standard for investigational use. “Every model update deployed to a trial system should require a version identifier logged in the trial master file,” the post says, “a documented assessment of whether the update constitutes
Drugs
In advance of a 4/30 meeting of the FDA Oncologic Drugs Advisory Committee (ODAC) to discuss AstraZeneca’s breast cancer drug camizestrant, agency medical reviewers are raising concerns and asking the committee to consider whether there is a favorable benefit-risk assessment. The agency briefing document says camizestrant is
Drugs
FDA has accepted for priority review a GSK NDA for its investigational hepatitis B treatment bepirovirsen. The agency set a user fee review action target date of 10/26. The investigational antisense oligonucleotide is being developed for adults with chronic hepatitis B, a viral infection that affects more than 250
Drugs
FDA has released the form FDA-483 issued following a 3/4-3/11/2025 inspection at the Fujifilm Diosynth Biotechnologies Texas drug manufacturing facility in College Station, TX. The eight inspection observations were: * failure to adequately control the multi-product manufacturing areas to prevent potential cross-contamination; * the quality