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HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “ …
HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “ …
For Immediate Release: August 14, 2025 Today, the U.S. Food and Drug Administration approved Papzimeos (zopapogene imadenovec-drba), a first-of-its-kind non-replicating adenoviral vector-based immunotherapy for the treatment of adult patients with …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company …
Image The U.S. Food and Drug Administration is responsible for protecting the public health by, among other things, ensuring the safety and effectiveness of drugs, biological products and medical devices. In certain circumstances, the FDA allows the …
Millions of children receive anesthesia and sedation drugs each year for surgeries and procedures; however, until recently, little was known about these drugs’ effects on the developing brain. Research studies have found that early exposure in juvenile …
On This Page Date: September 10, 2025 Time: 1:00 p.m. - 5:00 p.m. ET FDA and the Duke-Margolis Institute for Health Policy will host a virtual workshop on September 10, 2025 that will delve into the challenges and strategies for expedited chemistry, …
For Immediate Release: August 13, 2025 Statement From: Martin A Makary, M.D., M.P.H. Commissioner of Food and Drugs - Food and Drug Administration Today I applaud Florida Attorney General James Uthmeier’s bold efforts to protect Floridians by filing an …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
On This Page Date: December 5, 2025 Time: 8:00 a.m. - 4:00 p.m. ET Location: Event Location FDA, White Oak Campus, The Great Room Building 31 10903 New Hampshire Avenue Silver Spring, MD 20903 United States This meeting comes at a critical time for …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
Summary Company Announcement Date: August 12, 2025 FDA Publish Date: August 12, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Due to potential safety and performance concerns Company Name: Max Mobility, LLC. Brand …
Summary Company Announcement Date: August 11, 2025 FDA Publish Date: August 12, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential presence of glass Company Name: Dollar General Corporation Brand Name: …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
On This Page Date: September 23 - 24, 2025 Day1: Tue, Sep 23 8:30 a.m. - 05:30 p.m. ET Day2: Wed, Sep 24 8:30 a.m. - 04:20 p.m. ET Location: Event Location The Universities at Shady Grove Building II 9630 Gudelsky Drive Rockville, MD 20850 United States …
On This Page Date: September 11, 2025 Time: 12:00 p.m. - 2:00 p.m. ET This webinar will provide an in-depth look at the draft ICH M13B guideline titled "Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver…
[December 8, 2025] The U.S. Food and Drug Administration today approved the first generic version of Imvexxy® (estradiol vaginal inserts). This approval will provide women additional options for access to treatment of moderate to severe dyspareunia ( …
[12/8/2025] The U.S. Food and Drug Administration (FDA) has qualified the first AI drug development tool, the AI-Based Histologic Measurement of NASH (AIM-NASH), to help pathologists assess metabolic dysfunction-associated steatohepatitis (MASH) disease …
Summary Company Announcement Date: August 07, 2025 FDA Publish Date: August 12, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential speaker-related issue that can trigger an error resulting in a discontinuation …
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