103 Result: FDA
FDA Issues Emergency Use Authorization for Drug for Short-Term Prevention of New World Screwworm in Horses
July 15th, 2026
Silver Spring, MD / CRWE PRESS RELEASE / July 15, 2026 - To advance the Trump administration’s actions to safeguard American agriculture, the U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Ivermectin Liq. Read more
FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing
June 30th, 2026
Agency selects seven companies to expand domestic pharmaceutical manufacturing, increase production capacity, and strengthen U.S. drug supply chain resilience Silver Spring, MD / CRWE PRESS RELEASE / June 29, 2026 - Today, the U.S. Food and D. Read more
FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose
June 16th, 2026
Silver Spring, MD / CRWE PRESS RELEASE / June 16, 2026 - The U.S. Food and Drug Administration (FDA) today approved another over-the-counter (OTC) intranasal naloxone product, Rextovy, a 4 milligram (mg) naloxone hydrochloride nasal spray for th. Read more
FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients with Recently Diagnosed Stage 3 Type 1 Diabetes
June 15th, 2026
First disease modifying therapy approval for new onset stage 3 diabetes represents a significant milestone for the pediatric type 1 diabetes community Silver Spring, MD / CRWE PRESS RELEASE / June 15, 2026 - On June 12, 2026, the U.S. F. Read more
FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children
June 12th, 2026
Silver Spring, MD / CRWE PRESS RELEASE / June 12, 2026 - The U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosenso. Read more
FDA Issues Emergency Use Authorization for Generic Over-the-Counter Drug to Treat New World Screwworm in Dogs and Cats
June 11th, 2026
Most dogs and cats in the U.S. are at low risk of NWS; risk is elevated for pets recently in areas with confirmed cases of NWS Silver Spring, MD / CRWE PRESS RELEASE / June 11, 2026 - The U.S. Food and Drug Administration today issued an Emergency. Read more
FDA Expands Sunscreen Options for the First Time in 20 Years
June 09th, 2026
Silver Spring, MD / CRWE PRESS RELEASE / June 09, 2026 - Today, the U.S. Food and Drug Administration added bemotrizinol to the list of permitted sunscreen active ingredients, marking a significant milestone in the agency's efforts to advance sunscre. Read more
FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs
May 29th, 2026
Streamlined approach could reduce time and cost to bring new cancer drugs into human trials Silver Spring, MD / CRWE PRESS RELEASE / May 29, 2026 - The U.S. Food and Drug Administration today issued a draft guidance to reduce unnecessary anim. Read more
FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
May 22nd, 2026
Silver Spring, MD / CRWE PRESS RELEASE / May 22, 2026 - Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advance. Read more
FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia
April 30th, 2026
Silver Spring, MD / CRWE PRESS RELEASE / April 30, 2026 - The U.S. Food and Drug Administration today approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets to treat agitat. Read more
FDA Releases Results from Largest-Ever Testing of Infant Formula in the U.S.
April 29th, 2026
Agency to Continue Rigorous Oversight and Additional Testing Silver Spring, MD / CRWE PRESS RELEASE / April 29, 2026 - The U.S. Food and Drug Administration today announced results from the largest and most rigorous exami. Read more
FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order
April 24th, 2026
Agency issues priority vouchers, clears new clinical research, and advances guidance to support treatments for depression, PTSD, and substance use disorders Silver Spring, MD / CRWE PRESS RELEASE / April 24, 2026 - President Trump on April 18. Read more
Treasury, IRS Announce Process for Tax Guidance Following DOJ Final Order on Medical Marijuana Rescheduling
April 23rd, 2026
WASHINGTON, D.C. / CRWE PRESS RELEASE / April 23, 2026 - Today, the U.S. Department of the Treasury and the Internal Revenue Service (IRS) announce that they plan to issue guidance that addresses the federal tax consequences of t. Read more
FDA Approves First-Ever Gene Therapy for Treatment of Genetic Hearing Loss Under National Priority Voucher Program
April 23rd, 2026
Groundbreaking AAV-based gene therapy offers potential treatment for patients with OTOF gene-associated severe-to-profound and profound hearing loss Silver Spring, MD / CRWE PRESS RELEASE / April 23, 2026 - The U.S. Food and Drug Administrati. Read more
FDA Achieves Year 1 Goals in Reducing Animal Testing in Drug Development
April 20th, 2026
Since publishing roadmap last April, agency has successfully launched several key initiatives to replace animal testing with better alternatives Silver Spring, MD / CRWE PRESS RELEASE / April 20, 2026 - The U.S. Food and Drug Administration t. Read more
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