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99 Result: FDA

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FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs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trials Silver Spring, MD / CRWE PRESS RELEASE / May 29, 2026 - The U.S. Food and Drug Administration today issued a draft guidance to reduce unnecessary anim.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

FDA Releases Results from Largest-Ever Testing of Infant Formula in the U.S.

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

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

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99 Result: FDA

FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children

FDA Issues Emergency Use Authorization for Generic Over-the-Counter Drug to Treat New World Screwworm in Dogs and Cats

FDA Expands Sunscreen Options for the First Time in 20 Years

FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs

FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection

FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia

FDA Releases Results from Largest-Ever Testing of Infant Formula in the U.S.

FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order

Treasury, IRS Announce Process for Tax Guidance Following DOJ Final Order on Medical Marijuana Rescheduling

FDA Approves First-Ever Gene Therapy for Treatment of Genetic Hearing Loss Under National Priority Voucher Program

FDA Achieves Year 1 Goals in Reducing Animal Testing in Drug Development

FDA Takes Step Forward on Testosterone Therapy for Men

FDA Approves First New Molecular Entity Under National Priority Voucher Program

FDA Approves First Gene Therapy for Severe Leukocyte Adhesion Deficiency Type I

FDA Approves Drug to Treat Neurologic Manifestations of Hunter Syndrome

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99 Result: FDA

FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children

FDA Issues Emergency Use Authorization for Generic Over-the-Counter Drug to Treat New World Screwworm in Dogs and Cats

FDA Expands Sunscreen Options for the First Time in 20 Years

FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs

FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection

FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia

FDA Releases Results from Largest-Ever Testing of Infant Formula in the U.S.

FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order

Treasury, IRS Announce Process for Tax Guidance Following DOJ Final Order on Medical Marijuana Rescheduling

FDA Approves First-Ever Gene Therapy for Treatment of Genetic Hearing Loss Under National Priority Voucher Program

FDA Achieves Year 1 Goals in Reducing Animal Testing in Drug Development

FDA Takes Step Forward on Testosterone Therapy for Men

FDA Approves First New Molecular Entity Under National Priority Voucher Program

FDA Approves First Gene Therapy for Severe Leukocyte Adhesion Deficiency Type I

FDA Approves Drug to Treat Neurologic Manifestations of Hunter Syndrome

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