FDA
The Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services (HHS). The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed, and veterinary products.
Beyond's analysis on FDA
- — FDA approval of Fayuvi gene therapy marks a critical milestone for Ultragenyx's commercial trajectory and 2027 profit targets
- — Clearmind Medicine engages with FDA in landmark psychedelic therapy hearing
- — IASO Bio secures FDA clearance for first China-origin lentiviral in vivo CAR-T therapy
- — ZBeats gains FDA 510(k) clearance for ZBPro Diagnostic v2.0, enabling up to 14‑day ECG analysis via wearable patches
- — Capricor Therapeutics faces growing legal pressure as investors approach deadline for class action leadership amidst FDA review uncertainties
- — Outlook Therapeutics focuses on commercializing LYTENAVA following FDA regulatory milestones
- — Prelude Therapeutics advances toward clinical trials for first-in-class oral KAT6A degrader following FDA IND clearance
- — CraniUS Therapeutics secures FDA 510(k) clearance for its patient-specific cranial implant platform
- — Opus Genetics advances OPGx-BEST1 toward Phase 3 after positive low-dose clinical data and successful FDA alignment
- — Alebund Pharmaceuticals gains FDA clearance to initiate clinical trials for IgA nephropathy treatment
- — Karmanos Cancer Institute begins offering the newly FDA‑approved KRAS G12C inhibitor daraxonrasib (Rasonque) for metastatic pancreatic cancer, marking the first clinical rollout of a targeted therapy for a historically hard‑to‑treat malignancy
- — FDA clears Caliway's CBL-514 combo with tirzepatide for Phase 2 trial as pivotal Phase 3 SUPREME-01 starts enrollment
Recent news mentioning FDA
- — Humane World for Animals Commends FDA for removing animal testing references from drug regulations
- — KVK-Tech Completes FDA REMS Inspection with No Observations
- — Teal Health Raises $22 Million Series A to Expand Access to the Most Accurate FDA-Authorized At-Home HPV Cervical Cancer Screening
- — AIM ImmunoTech Highlights Ampligen’s Potential Role in the Evolving Pancreatic Cancer Treatment Landscape Following FDA Approval of Revolution Medicines’ Daraxonrasib
- — Palisade Bio Receives FDA Clearance of IND for PALI-2108 in Crohn’s Disease, Expanding Phase 2 Development Across IBD
- — Myrava Advances Personalized Radiation Therapy With FDA 510(k) Clearance for Patient-Specific 3D Printed Bolus Device
- — Quoin Pharmaceuticals Announces FDA Fast Track Designation for QRX003 for the Treatment of Peeling Skin Syndrome
- — Compass Therapeutics Provides Regulatory Update on Tovecimig in Biliary Tract Cancer Following FDA Feedback
- — Natural design. Amplified: Smith+Nephew announces FDA 510(k) clearance and first surgical cases of LANDMARK™ Total Knee System
- — Decoy Therapeutics Exploring Pan-Filovirus Program via FDA Animal Rule Pathway and Non-Dilutive Funding
- — SystImmune Receives FDA Clearance of IND Application for Bispecific Antibody SI-B037
- — FDA Approves Fayuvi. What Does It Mean for Ultragenyx (RARE)’s 2027 Profitability Target?