FDA

269 articles in the TruthFoundry index. Each links out to the original.

• US FDA Approves Multiple New Pharmaceutical Treatments 2022-2026 · This listing documents US FDA drug approvals issued between late 2022 and October 2026.
• FDA Approves First Once-Weekly Insulin For Pediatric Type 2 Diabetes · FDA approved Awiqli, the first once-weekly insulin for children 10+ with type 2 diabetes.
• FDA Publishes Multiple 2026 Biologics And Regulatory Guidance Documents · US FDA released new and draft industry guidance documents between July and October 2026.
• FDA publishes Patient Listening Session program details and summaries · FDA Office of Public Engagement manages quarterly reviewed patient listening sessions.
• FDA Oversees Generic Drug Approval And Availability For US Patients · 90% of US prescriptions are generic drugs, overseen by the FDA Office of Generic Drugs.
• FDA outlines handling of expanded drug access safety event data · FDA explains evaluation practices for adverse events from expanded drug access programs.
• Tabulated list of approved generic pharmaceutical therapies · This dataset lists generic drug approvals with manufacturer, formulation and date details.
• FDA schedules public meeting for Rare Disease Framework Initiative · FDA will host a hybrid public meeting for its Rare Disease Framework Initiative on 2026-10-28.
• FDA Releases FY 2027 OTC Monograph Drug User Fee Program Details · FDA published FY 2027 OMUFA facility fee rules, amounts, and payment deadlines.
• FDA Compounding Quality Center launches two industry discussion series · FDA Compounding Quality Center announces two discussion series for drug compounding facilities.
• FDA Requests Removal of Key Risks From Menopausal Hormone Therapy Boxed Warnings · US FDA orders removal of cardiovascular, cancer, dementia risks from HRT boxed warnings.
• FDA publishes downloadable tab-delimited Drugs@FDA database export · FDA provides a compressed tab-delimited export of the Drugs@FDA database for technical users.
• FDA and ARC Program Advance Rare Disease Drug Development in 2025 · The FDA and ARC Program highlighted key milestones in rare disease approvals, orphan drug designations, and collaborative workshops.
• FDA GDUFA Type II API DMF Payment Receipts Reported for FY 2023-2026 · The FDA reports monthly GDUFA Type II API DMF payment receipt counts from FY 2023 through FY 2026.
• 47 Novel Pharmaceutical Drugs Received Official Approval During 2026 · This document catalogs 47 new pharmaceutical drugs approved in 2026 with clinical indications.
• FDA Approves First-of-Kind Chronic Hepatitis B Treatment Hibsago · US FDA approved GSK's Hibsago, first antisense oligonucleotide for chronic hepatitis B.
• FDA Warns Consumers About Dangerous Fraudulent Health Products · FDA alerts public to serious health risks from unproven fraudulent health products.
• FDA Releases New Guidance Documents on Drug Development and Clinical Trials · The FDA published a series of final and draft guidance documents covering clinical trials, biosimilars, and drug manufacturing specifications.
• FDA Issues Technical Specifications for Clinical Trial Driving Study Data Submission · FDA provides Level 2 guidance on submitting clinical trial data to evaluate motor vehicle operation ability.
• FDA grants regular approval for pralsetinib in RET fusion-positive lung cancer · The FDA approved pralsetinib for adult patients with metastatic RET fusion-positive non-small cell lung cancer.
• FDA Approves First Generic Once-Weekly Menopause Hormone Therapy Patch · US FDA approved the first generic Climara Pro once-weekly hormone patch on October 20, 2026.
• FDA Sets Annual Generic Drug Research Priorities Under GDUFA · The FDA consults with industry and the public to establish yearly regulatory science initiatives for generic drugs.
• FDA Regulates OTC Drugs; 2020 CARES Act Updated Rules · US FDA outlines over-the-counter drug regulation and CARES Act reform provisions.
• FDA Unveils Stakeholder Plan for Nonprescription Drug Market Access · FDA launched a stakeholder engagement plan to facilitate the development and approval of nonprescription drug products.
• FDA issues warning letter to Signature Formulations over contaminated drugs · US FDA issued a formal warning letter to Signature Formulations LLC for adulterated drug products.
• FDA warns Rohto Vietnam over falsified drug manufacturing data · FDA issued a warning letter to Rohto Vietnam for falsifying environmental and cleaning records during drug manufacturing.
• FDA warns SnugZ USA over OOS testing failures and inadequate investigations · FDA issued a warning letter to SnugZ USA for failing to investigate out-of-specification drug test results.
• FDA warns Zhejiang Gaorong Cosmetic Co. for OTC drug manufacturing violations · FDA issued a warning letter to Zhejiang Gaorong Cosmetic Co. for failing to test OTC drug components and verify supplier reliability.
• FDA warns Baxter International over drug manufacturing contamination risks · FDA issued a warning letter to Baxter International for CGMP violations regarding potential cephalosporin cross-contamination.
• FDA Issues Final Guidance on Prescription Drug Apps and Software · FDA releases final guidance clarifying regulatory requirements for prescription drug companion apps and standalone software.