108 Result: FDA
FDA Issues Emergency Use Authorization for Drug to Treat New World Screwworm in Dogs and Puppies
August 13th, 2026
Silver Spring, MD / CRWE PRESS RELEASE / August 13, 2026 - The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Simparica TRIO (sarolaner, moxidectin, and pyrantel chewable tablets) for the treatment of New. Read more
FDA Issues Emergency Use Authorization for Drug to Prevent New World Screwworm in Multiple Species, Including Sheep, Cattle, Goats, and Swine
August 07th, 2026
Silver Spring, MD / CRWE PRESS RELEASE / August 7, 2026 - The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for CLiK Extra (dicyclanil topical suspension) wound spray for application on or around wounds for . Read more
FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced Melanoma
August 06th, 2026
Approval Offers New Hope for Patients with Anti-PD-1 Refractory Melanoma Silver Spring, MD / CRWE PRESS RELEASE / August 6, 2026 - The U.S. Food and Drug Administration today granted accelerated approval to Tudriqev (vusolimogene oderparepvec. Read more
FDA Approves First Drug to Treat the Full Range of Narcolepsy Type 1 Symptoms
August 05th, 2026
New drug is the first to directly restore orexin signaling, targeting the underlying biological cause of narcolepsy type 1 Silver Spring, MD / CRWE PRESS RELEASE / August 5, 2026 - The U.S. Food and Drug Administration today approved Orz. Read more
FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot
July 22nd, 2026
Silver Spring, MD / CRWE PRESS RELEASE / July 22, 2026 - The U.S. Food and Drug Administration today announced the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. The p. Read more
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
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August 15th, 2026FDA Issues Emergency Use Authorization for Drug to Treat New World Screwworm in Dogs and Puppies
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