For Immediate Release: March 05, 2026 The U.S. Food and Drug Administration today issued a Request for Information (RFI) seeking public comment on potential new standards for in-home opioid disposal products. This effort is part of the agency’s broader …
For Immediate Release: March 05, 2026 The U.S. Food and Drug Administration today approved teclistamab in combination with daratumumab hyaluronidase-fihj, Tec-Dara, to treat adult patients with relapsed or refractory multiple myeloma who have received at …
For Immediate Release: March 06, 2026 Earlier this week, the U.S. Food and Drug Administration held a meeting with several states to discuss the section 804 importation program (SIP), which allows states and Indian tribes to import certain prescription …
For Immediate 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 patients who have a confirmed variant …
For Immediate Release: March 11, 2026 The U.S. Food and Drug Administration today launched a new unified platform for analyzing adverse event reports. This platform — called the FDA Adverse Event Monitoring System (AEMS) — represents a major achievement in …
Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-26-53 Product: Drugs Recipient: Recipient Name Ms. Lauren Szarzynski Microbiological Testing & Consulting, LLC 5661 W. 120th Street Alsip, IL 60803 United States lauren@mtcresearch.com …
Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-26-55 Product: Animal & Veterinary Drugs Recipient: Recipient Name Mr. He Jingyin Recipient Title General Manager Henan Lvyuan Pharmaceutical Co. Ltd. Industrial Park, Qiliying Town Xinxiang …
After reviewing postmarketing data from the applicant's submission (cases from their global safety database), the literature, and the FDA Adverse Event Reporting System (FAERS) database, which has been incorporated into the FDA Adverse Event Monitoring …
Registrants, including repackers and relabelers, are required under federal law to report annually to the agency the amount of each listed drug that was manufactured, prepared, propagated, compounded or processed for commercial distribution. Registrants …
Alyglo (immune globulin intravenous, human-stwk) Increased hypersensitivity reactions in patients receiving certain product lots FDA is evaluating the need for regulatory action. Bispecific T-cell engager therapies Columvi (glofitamab-gxbm) injection …
FDA Adverse Event Monitoring System (AEMS) FDA is implementing the Adverse Event Monitoring System (AEMS) to consolidate multiple disparate reporting systems currently used across all FDA-regulated product categories, including medical products, vaccines, …
[3-30-2026] The Food and Drug Administration is advising consumers not to purchase or use Red Bull Extreme or Blue Bull Extreme, products promoted and sold for sexual enhancement on various websites and possibly in some retail stores. These products were …
[3-30-2026] The Food and Drug Administration is advising consumers not to purchase or use Boner Bears Honey, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. This product was identified during an …
For Immediate 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). Kresladi is indicated for the …
For Immediate 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). “Today is a milestone day for children and …
For Immediate Release: March 20, 2026 As part of the U.S. Food and Drug Administration’s continuous quality improvement efforts, the agency today published a Federal Register Notice seeking public comment on the Commissioner’s National Priority Voucher …
For Immediate Release: March 19, 2026 The U.S. Food and Drug Administration today approved a new higher dose (7.2 mg) of Wegovy (semaglutide) injection, called Wegovy HD, for weight loss and long-term maintenance of weight loss for certain adult patients …
For Immediate 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 in drug development, and to bring …
en Español [Update 3-3-2026] FDA also is advising consumers not to purchase or use Artri Ajo Rey, a product promoted and sold for joint pain on various websites, https://naturistarex.com/, and possibly in some retail stores. FDA laboratory analysis …
[3/3/2026] Today, the U.S. Food and Drug Administration approved the first generic of Flovent HFA (fluticasone propionate) inhalation aerosol, 44 micrograms per actuation, for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 …
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