92 Result: FDA
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
FDA Takes Step Forward on Testosterone Therapy for Men
April 16th, 2026
Silver Spring, MD / CRWE PRESS RELEASE / April 16, 2026 - The U.S. Food and Drug Administration today is taking an initial step to advance treatment options for men’s health by encouraging sponsors of approved testosterone replacement ther. Read more
FDA Approves First New Molecular Entity Under National Priority Voucher Program
April 01st, 2026
Action marks the fastest approval of an NME since 2002 Silver Spring, MD / CRWE PRESS RELEASE / April 01, 2026 - The U.S. Food and Drug Administration today approved Foundayo (orforglipron), marking the fifth approval under the Commissioner's Nati. Read more
FDA Approves First Gene Therapy for Severe Leukocyte Adhesion Deficiency Type I
March 26th, 2026
Silver Spring, MD / CRWE PRESS RELEASE / March 26, 2026 - The U.S. Food and Drug Administration today approved Kresladi (marnetegragene autotemcel), the first gene therapy for the treatment of severe Leukocyte Adhesion Deficiency Type I (LAD-I).. Read more
FDA Approves Drug to Treat Neurologic Manifestations of Hunter Syndrome
March 25th, 2026
Silver Spring, MD / CRWE PRESS RELEASE / March 25, 2026 - The U.S. Food and Drug Administration approved Avlayah (tividenofusp alfa-eknm) to treat certain individuals with Hunter syndrome (Mucopolysaccharidosis type II or MPS II). &ldq. Read more
FDA Releases Draft Guidance on Alternatives to Animal Testing in Drug Development
March 18th, 2026
Silver Spring, MD / CRWE PRESS RELEASE / March 18, 2026 - The U.S. Food and Drug Administration today issued a draft guidance intended to help drug developers validate new approach methodologies (NAMs) to be used instead of animal testing i. Read more
FDA Approves First Treatment for Patients with Cerebral Folate Transport Deficiency
March 10th, 2026
Silver Spring, MD / CRWE PRESS RELEASE / March 10, 2026 - The U.S. Food and Drug Administration today approved expanded use of Wellcovorin (leucovorin calcium) tablets for the treatment of cerebral folate deficiency in adult and pediatric p. Read more
FDA Approves First-of-Its-Kind Device to Treat Pancreatic Cancer
February 12th, 2026
Device Delivers Non-invasive Therapy and Supports Care at Home Silver Spring, MD / CRWE PRESS RELEASE / February 12, 2026 - The U.S. Food and Drug Administration has approved a first-of-its-kind device for the treatment of adult patient. Read more
FDA Takes New Approach to "No Artificial Colors" Claims
February 06th, 2026
Agency also grants two petitions to expand alternative food color options Silver Spring, MD / CRWE PRESS RELEASE / February 05, 2026 - Today, the U.S. Food and Drug Administration took additional steps to support the transition of our nation&. Read more
FDA Approves First Treatment for Children With Menkes Disease
January 13th, 2026
Silver Spring, MD / CRWE PRESS RELEASE / January 12, 2026 - The U.S. Food and Drug Administration today approved the Zycubo (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients. “With today&rs. Read more
FDA Approves Two Oral Therapies to Treat Gonorrhea
December 13th, 2025
Approvals Are for Uncomplicated Urogenital Gonorrhea Silver Spring, MD / CRWE PRESS RELEASE / December 12, 2025 - The U.S. Food and Drug Administration recently approved two new oral medicines to treat a common sexually transmitted infection calle. Read more
FDA Approves Nerve Scaffold for the Treatment of Sensory Nerve Discontinuity
December 04th, 2025
Silver Spring, MD / CRWE PRESS RELEASE / December 3, 2025 - The U.S. Food and Drug Administration today granted approval for Avance (acellular nerve allograft-arwx) in surgical implantation. Avance is a peripheral nerve scaffold approved for sensory . Read more
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