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

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

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

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

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

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

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

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

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

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

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

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

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

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

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