Government ❯Regulatory Agencies ❯FDA

Drug Approval Process

Compounding Regulations Public Health Over-the-Counter Drugs Public Health Regulations MDMA for PTSD 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 Telemedicine Regulations Patient Safety Labeling Regulations Biologics License Application Vaccine Licensing Vaccine Approval Import Regulations MDMA MDMA Trials Alzheimer's Drug Approval Insulin Icodec

ATyr’s Sarcoidosis Drug Fails Phase 3 Goal, Shares Plunge Over 80%

The company plans an FDA meeting to review nominal signals from the trial.

FDA Creates 'Green List' for GLP-1 Ingredients as WHO Names the Drugs Essential

Kennedy Alleges Biden Team Skewed Abortion-Pill Data as FDA Review of Mifepristone Proceeds

FDA Warns Five Brands Over Unauthorized Mousse Sunscreens

FDA Mandates Opioid Label Overhaul to Quantify Long-Term Risks

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

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