120 Result: FDA
FDA Launches New Program to Advance Neuroscience Medical Product Development
October 22nd, 2026
Neuroscience Advancement and Innovation Nexus to coordinate agency action on brain and nervous system conditions, with inaugural focus on Alzheimer's prevention Silver Spring, MD / CRWE PRESS RELEASE / October 22, 2026 - The U.S. Food a. Read more
FDA Approves First-of-Its-Kind Chronic Hepatitis B Treatment
October 21st, 2026
New treatment may allow some patients to maintain viral control after stopping all hepatitis B therapy Silver Spring, MD / CRWE PRESS RELEASE / October 20, 2026 - The U.S. Food and Drug Administration today approved Hibsago (bepirovirsen) inj. Read more
FDA Approves Once-Weekly Generic Hormone Therapy Patch for Women
October 20th, 2026
Silver Spring, MD / CRWE PRESS RELEASE / October 20, 2026 - The U.S. Food and Drug Administration yesterday approved the first generic of Climara Pro (estradiol and levonorgestrel transdermal system, 0.045 mg per day/0.015 mg), a transdermal hor. Read more
FDA Approves Immunotherapy That May Allow Certain Patients with Rectal Cancer to Avoid Chemotherapy, Radiation and Surgery
October 19th, 2026
Silver Spring, MD / CRWE PRESS RELEASE / October 19, 2026 - The U.S. Food and Drug Administration today granted accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab-gxly) that may allow some patients with locally advanc. Read more
FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer
October 14th, 2026
Expanded approval of Anktiva marks a new FDA approach to using evidence across closely related forms of bladder cancer Silver Spring, MD / CRWE PRESS RELEASE / October 14, 2026 - The U.S. Food and Drug Administration today expanded the approved us. Read more
FDA Investigation Leads to Charges Against Two Indian Nationals Involved in Transnational Counterfeit Drug Distribution Scheme
September 29th, 2026
Silver Spring, MD / CRWE PRESS RELEASE / September 29, 2026 - The U.S. Attorney’s Office for the Middle District of Florida and the Criminal Division of the U.S. Department of Justice today announced federal charges against Swapnadip Roy, . Read more
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
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