Delivery Method: Via UPS and EMAIL Reference #: CBER 25-710860 Product: Biologics Recipient: Recipient Name Glen G. Gong, PhD Recipient Title Chief Executive Officer Microvascular Tissue, Inc. 6199 Cornerstone Court East, Suite 109 San Diego, CA 92121 …
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Delivery Method: Via Email Reference #: 320-26-25 Product: Drugs Recipient: Recipient Name Mr. Ross Sklar Recipient Title Chief Executive Officer Sklar Personal Care Inc. 3137 East 26th Street Vernon, CA 90058 United States Ross@starcobrands.com Issuing …
Delivery Method: VIA UPS Reference #: 320-26-23 Product: Drugs Recipient: Recipient Name Marc S. Berridge, Ph.D. Recipient Title President 3D Imaging Drug Design and Development LLC 9015 Carti Way Little Rock, AR 72205 United States Issuing Office: Center …
WARNING LETTER December 12, 2025 RE: 719339 Musclepower Enterprise Ltd. dba MONSTER KING and GE LABS: This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at the Internet addresses https://www.monsterking.eu/ …
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 …
The U.S. Food and Drug Administration (FDA) has approved Cardamyst (etripamil) nasal spray to treat episodes of paroxysmal supraventricular tachycardia (PSVT), a condition where the heart beats abnormally fast. Disease or Condition People with paroxysmal …
For Immediate Release: December 15, 2025 The U.S. Food and Drug Administration today reminded industry of its legal responsibilities under the Federal Food, Drug, and Cosmetic Act regarding food recalls and called for industry to increase adoption of best …
Docket Number: FDA-2019-D-1264 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance recommends approaches that sponsors of clinical trials intended to support a new drug …
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On December 15, 2025, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or …
For Immediate Release: December 15, 2025 The U.S. Food and Drug Administration (FDA) today removed a key limitation on the use of real-world evidence (RWE) used in drug and device applications reviews. In new guidance for certain types of medical device …
For Immediate Release: December 15, 2025 The U.S. Food and Drug Administration today awarded a national priority voucher to teclistamab in combination with daratumumab for relapsed/refractory multiple myeloma. This brings the total number of products …
Docket Number: FDA-2021-D-0368 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research Oncology Center of Excellence The guidance is intended to help …
Docket Number: FDA-2020-D-2099 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The guidance provides recommendations for sponsors and sponsor-investigators to comply with the requirements of investigational new drug application ( …
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 …
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: December 12, 2025 FDA Publish Date: December 12, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Aluminum saucepans recalled because they have the potential to be contaminated …
FDA News Release Approvals Are for Uncomplicated Urogenital Gonorrhea For Immediate Release: December 12, 2025 The U.S. Food and Drug Administration recently approved two new oral medicines to treat a common sexually transmitted infection called gonorrhea …
On December 12, 2025, the Food and Drug Administration approved niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.) with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic castration-sensitive …
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