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Media Affairs @FDAMedia
Joined May 2014
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Media Affairs
@FDAMedia
25 Sep 2025
FDA Authorizes Marketing of First Eyeglass Lenses to Slow Progression of Pediatric Myopia bit.ly/4myXtKk

FDA Authorizes Marketing of First Eyeglass Lenses to Slow Progression of Pediatric Myopia

Today, the U.S. Food and Drug Administration authorized marketing of the Essilor Stellest eyeglass lenses to correct myopia, commonly referred to as nearsightedness, with or without astigmatism and...

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Media Affairs
@FDAMedia
25 Sep 2025
FDA Removes Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa (vandetanib) bit.ly/4mU1tpf

FDA Removes Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa (vandetanib)

The U.S. Food and Drug Administration today announced that it has eliminated special safety requirements to monitor for serious heart rhythm problems in patients taking Caprelsa (vandetanib), an...

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Media Affairs
@FDAMedia
23 Sep 2025
FDA Responds to Evidence of Possible Association Between Autism and Acetaminophen Use During Pregnancy bit.ly/4pBggY9

FDA Responds to Evidence of Possible Association Between Autism and Acetaminophen Use During...

The U.S. Food and Drug Administration today initiated the process for a label change for acetaminophen (Tylenol and similar products) to reflect evidence suggesting that the use of acetaminophen by...

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Media Affairs
@FDAMedia
23 Sep 2025
FDA Takes Action to Make a Treatment Available for Autism Symptoms bit.ly/4pINs0b

FDA Takes Action to Make a Treatment Available for Autism Symptoms

The U.S. Food and Drug Administration today initiated the approval of leucovorin calcium tablets for patients with cerebral folate deficiency (CFD), a neurological condition that affects folate (a...

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Media Affairs
@FDAMedia
19 Sep 2025
FDA Grants Accelerated Approval to First Treatment for Barth Syndrome bit.ly/3I73wId

FDA Grants Accelerated Approval to First Treatment for Barth Syndrome

The U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first treatment for Barth syndrome, in patients weighing at least 30 kg.

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Media Affairs
@FDAMedia
12 Sep 2025
FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products bit.ly/3JYtM86

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@FDAMedia
10 Sep 2025
HHS, CBP Seize $86.5 Million Worth of Illegal E-Cigarettes in Largest-Ever Operation bit.ly/45YUxBN

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@FDAMedia
10 Sep 2025
FDA Issues New Guidance to Expand Non-Opioid Options for Chronic Pain, Curb Misuse bit.ly/4mRtzSF

FDA Issues New Guidance to Expand Non-Opioid Options for Chronic Pain, Curb Misuse

As part of its broader strategy to address the opioid crisis, the U.S. Food and Drug Administration today issued draft guidance titled “Development of Non-Opioid Analgesics for Chronic Pain” to...

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FDA Launches Crackdown on Deceptive Drug Advertising bit.ly/4mT5x9H

FDA Launches Crackdown on Deceptive Drug Advertising

The U.S. Department of Health and Human Services and the Food and Drug Administration today announced sweeping reforms to rein in misleading direct-to-consumer pharmaceutical advertisements.

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FDA Approves Expanded Use of Vonvendi for von Willebrand Disease, Including for Certain Uses for Children bit.ly/46kvysN

FDA Approves Expanded Use of Vonvendi for von Willebrand Disease, Including for Certain Uses for...

The U.S. Food and Drug Administration today approved expanded use of Vonvendi [von Willebrand factor (Recombinant)] for routine preventative (prophylactic) use in adults (age 18 years and older) with...

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FDA Launches Green List to Protect Americans from Illegal Imported GLP-1 Drug Ingredients bit.ly/484qvhj

FDA Launches Green List to Protect Americans from Illegal Imported GLP-1 Drug Ingredients

The U.S. Food and Drug Administration today established a “green list” import alert to help stop potentially dangerous GLP-1 (glucagon-like peptide-1) active pharmaceutical ingredients (APIs) from...

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FDA Announces Real-Time Release of Complete Response Letters, Posts Previously Unpublished Batch of 89 bit.ly/4m3urCq

FDA Announces Real-Time Release of Complete Response Letters, Posts Previously Unpublished Batch of...

Agency continues to promote radical transparency in regulatory decision-making

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FDA Advances Rare Disease Drug Development with New Evidence Principles bit.ly/4lYA0C7

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FDA Urges Nicotine Pouch Manufacturers To Use Child-Resistant Packaging Following Increasing Reports of Accidental Exposure bit.ly/4p47iT2

FDA Urges Nicotine Pouch Manufacturers To Use Child-Resistant Packaging Following Increasing...

The U.S. Food and Drug Administration calls on nicotine pouch manufacturers to use child-resistant packaging to protect American children from accidental, harmful exposure.

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Media Affairs
@FDAMedia
22 Aug 2025
FDA Begins Real-Time Reporting of Adverse Event Data bit.ly/41isM4z

FDA Begins Real-Time Reporting of Adverse Event Data

The U.S. Food and Drug Administration (FDA) today began publishing adverse event data on a daily basis, giving the public faster access to information on serious medication errors and product quality...

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@FDAMedia
19 Aug 2025
HHS Allows FDA Emergency Use of Animal Drugs to Combat New World Screwworm, Protect U.S. Food Supply bit.ly/3HFvV7F

HHS Allows FDA Emergency Use of Animal Drugs to Combat New World Screwworm, Protect U.S. Food Supply

The U.S. Department of Health and Human Services (HHS) today issued a declaration that allows the U.S. Food and Drug Administration (FDA) to issue Emergency Use Authorizations (EUAs) for animal drugs...

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Media Affairs
@FDAMedia
14 Aug 2025
FDA Approves First Immunotherapy for Recurrent Respiratory Papillomatosis bit.ly/47gchKb

FDA Approves First Immunotherapy for Recurrent Respiratory Papillomatosis

FDA approved Papzimeos, the first immunotherapy for use in adults with recurrent respiratory papillomatosis.

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Media Affairs
@FDAMedia
13 Aug 2025
Statement from FDA Commissioner Marty Makary, M.D., M.P.H., on Florida Restriction of 7-OH Opioid Products bit.ly/4oBqeZg

Statement from FDA Commissioner Marty Makary, M.D., M.P.H., on Florida Restriction of 7-OH Opioid...

Statement from FDA Commissioner Marty Makary, M.D., M.P.H., on Florida Restriction of 7-OH Opioid Products

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FDA Commissioner Makary, USDA Secretary Rollins Celebrate Proposed Modernization of Orange Juice Regulations to Benefit American Growers bit.ly/3HpLYXe

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A Statement from FDA Commissioner Marty Makary, M.D., M.P.H: Announcing Resolution of the IV Saline Solutions Shortage bit.ly/4foSvhi
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