114 Result: FDA
FDA Grants Accelerated Approval to a New Breast Cancer Treatment
September 04th, 2026
Silver Spring, MD / CRWE PRESS RELEASE / September 04, 2026 - The U.S. Food and Drug Administration today expanded treatment options for adult patients with advanced breast cancer, reflecting the FDA’s commitment to advancing medical innov. Read more
FDA Approves First Drug to Treat Alexander Disease
September 03rd, 2026
New therapy is the first to directly target the underlying cause of this rare neurological disease Silver Spring, MD / CRWE PRESS RELEASE / September 03, 2026 - The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) i. Read more
FDA Approves First Oral Drug Indicated to Treat Dermatomyositis in Adults
August 27th, 2026
Lisraya is the first FDA-approved oral treatment option for patients with dermatomyositis, addressing the high unmet need for this rare disease. Silver Spring, MD / CRWE PRESS RELEASE / August 27, 2026 - The U.S. Food and Drug Administration . Read more
FDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer
August 26th, 2026
Silver Spring, MD / CRWE PRESS RELEASE / August 26, 2026 - The U.S. Food and Drug Administration today approved Rasonque (daraxonrasib), a RAS inhibitor for the most common form of pancreatic cancer—delivering a new treatment option to pat. Read more
FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar
August 25th, 2026
New device can help people with diabetes detect warning signs of a dangerous complication before it becomes a medical emergency Silver Spring, MD / CRWE PRESS RELEASE / August 25, 2026 - The U.S. Food and Drug Administration today authorized . Read more
FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices
August 18th, 2026
Discussion Paper Supports FDA’s Innovation and Global Leadership Strategic Pillar; Public Docket Opens on Regulations.gov Silver Spring, MD / CRWE PRESS RELEASE / August 18, 2026 - The U.S. Food and Drug Administration today issued a di. Read more
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
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