Government ❯Regulatory Agencies ❯FDA

Drug Approval Process

Public Health Compounding Regulations Public Health Regulations MDMA for PTSD Insulin Icodec MDMA Approval Psychedelic Drugs Clinical Trials Clinical Trial Regulations Ranitidine Regulations Medication Safety Over-the-Counter Medications Accelerated Approval Tirzepatide Supply Breakthrough Therapy Designation Mifepristone Legislation Compliance Animal Welfare Policies Ethical Standards in Testing Animal Welfare Clinical Data Requirements Enforcement Actions Biotech Innovation Safety Concerns Mifepristone Review Clinical Study Regulations Safety Communications Market Withdrawal Risks MDMA MDMA Trials Alzheimer's Drug Approval

FDA Investigates Fatal Liver Failures Linked to Sarepta’s Elevidys Therapy

Two teenage deaths within 90 days of infusion prompted Sarepta to suspend shipments to non-ambulatory patients.

Sarepta Halts Elevidys Shipments for Non-Ambulatory Patients After Second Fatal Liver Failure

FDA Commissioner Pledges Safety Review of Abortion Pill Mifepristone

Abortion Pill Study Fuels Debate Over Safety and Access

Federal Judge Upholds FDA Ban on Compounded Ozempic and Wegovy Copies

Novo Nordisk Seeks FDA Approval as Eli Lilly's Weight-Loss Pill Advances

FDA Launches Immediate Plan to Replace Animal Testing with Human-Relevant Methods

FDA Launches Roadmap to Phase Out Animal Testing in Drug Development

FDA Declares Semaglutide Shortage Over, Impacting Compounded Drug Market

FDA to Decide on First Twice-Yearly HIV Prevention Shot by June

Eli Lilly Lowers 2024 Revenue Forecast Due to Slower Weight-Loss Drug Growth

FDA Moves to Ban Ineffective Cold Medicine Ingredient

Novo Nordisk Urges FDA to Ban Compounded Versions of Ozempic and Wegovy

Eli Lilly Sues Vendors for Selling Unauthorized Tirzepatide Products

CEO Sentenced to 3 Years for Selling Unapproved Stem Cell Treatments

FDA Declines MDMA for PTSD Treatment, Requests Further Trials

FDA Rejects MDMA for PTSD Treatment, Requests More Trials

FDA Panel Rejects MDMA for PTSD Treatment Over Data Concerns