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
FDA Policy/General
FDA is facing mounting internal strain and external criticism just over a year into commissioner Marty Makary’s tenure, according to accounts from agency staff, industry executives and policymakers, raising questions about leadership stability at the nation’s top drug regulator. Makary, initially viewed as a conventional and well-qualified
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
Biologics
A series of recent FDA regulatory decisions is sharpening focus on the evidentiary standards underpinning cell and gene therapy development, as sponsors face increasing difficulty translating early promise into approvable data packages — an issue highlighted in a recent opinion piece by Jenna DiRito, co-founder and chief operating officer of
FDA Policy/General
FDA has issued an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a consumer-facing Web site for its drug Amvuttra. In the letter, CDER’s Office of Prescription Drug Promotion said the Amvuttra Web page overstated the drug’s survival benefit in patients with transthyretin amyloid cardiomyopathy
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,
Biologics
FDA is planning a 6/4 town hall meeting aimed at guiding drug developers through the process of preparing BLAs for cell and gene therapy products. The CBER virtual session will feature regulatory experts addressing common questions about BLA readiness and submission strategies. Officials from the Office of Review Management
FDA Policy/General
The Pharmaceutical Research and Manufacturers of America (PhRMA) is urging FDA to broaden and clarify its draft guidance on individualized therapies, warning that overly narrow definitions and unclear expectations could hinder innovation in precision medicine. In formal comments submitted on the agency’s proposed “plausible mechanism” framework, PhRMA called for
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
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a YouTube video and Spanish-language TV ad for Bayer’s Nubeqa (darolutamide) tablets for oral use are misleading because they include claims and representations about the drug’s benefits but omit important risk information associated with it. A 4/28
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
FDA Policy/General
The U.S. House Appropriations Committee on Tuesday approved legislation to fund FDA for fiscal year 2027, advancing the measure to the full House after a largely party-line vote. The Agriculture/FDA spending bill cleared the committee 4/29 by a vote of 35–25, according to congressional materials.
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
FDA Policy/General
Purdue Pharma was sentenced 4/28 in federal court in Newark, NJ, to pay more than $5 billion in criminal penalties for its role in the U.S. opioid epidemic. The penalties include a $3.544 billion criminal fine and $2 billion in forfeiture, though up to $1.775 billion
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