U.S. Food and Drug Administration (FDA)

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The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed[4] and veterinary products. As of 2017, 3/4th of the FDA budget (approximately $700 million) is funded by the pharmaceutical companies due to the Prescription Drug User Fee Act. Source

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Language English, Spanish
Country United States of America
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FDA Approves Drug for Pediatric Stage 3 Type I Diabetes

| U.S. Food and Drug Administration (FDA)
The U.S. Food and Drug Administration (FDA) has approved Tzield (teplizumab) injection to delay (slow down) the loss of the body’s own insulin production for pediatric patients aged 8 to 17 years recently diagnosed with Stage 3 Type I diabetes (T1D). Condition Type 1 diabetes (T1D) develops in stages, which are determined by two things: the presence of certain proteins in the blood called autoantibodies and blood sugar levels.
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Tissue & Advanced Therapies Research

| U.S. Food and Drug Administration (FDA)
Home Vaccines, Blood & Biologics Science & Research (Biologics) Tissue & Advanced Therapies Research Science & Research (Biologics) Cellular Therapy Investigating the Effects of Cell-Materials Interactions on the Safety and Effectiveness of Cell-Based Products Kyung E.
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FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children

| U.S. Food and Drug Administration (FDA)
For Immediate 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 Biosensor System, an integrated CGM (iCGM) indicated for people two years of age and older who do not use insulin. The FDA previously cleared the Stelo Glucose Biosensor System OTC for individuals 18 years and older in March 2024.
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FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer

| U.S. Food and Drug Administration (FDA)
On June 12, 2026, the Food and Drug Administration approved capivasertib (Truqap, AstraZeneca) in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer) that is PTEN-deficient as detected by an FDA-authorized test.
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Azuma Foods International, Inc. Issues Allergy Alert on Undeclared Fish in Tako Wasabi

| U.S. Food and Drug Administration (FDA)
Summary Company Announcement Date: June 11, 2026 FDA Publish Date: June 12, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description May contain undeclared fish. Company Name: Azuma Foods International, Inc.
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Beekeeper’s Naturals Issues Voluntary Nationwide Recall of Beekeeper’s Naturals Saline Nasal Spray Sold Through Amazon Due to Microbial Contamination

| U.S. Food and Drug Administration (FDA)
Summary Company Announcement Date: June 11, 2026 FDA Publish Date: June 12, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Above acceptable microbiological limits for yeast and may contain Aspergillus spp. Company Name: Beekeeper’s Naturals Brand Name: Product Description: Company Announcement FOR IMMEDIATE RELEASE – June 11, 2026, Covina, CA - Beekeeper’s Naturals is voluntarily recalling lot # 5950, Exp.
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January - March 2024 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)

| U.S. Food and Drug Administration (FDA)
Akeega (niraparib and abiraterone acetate) Zejula (niraparib) Haemorrhage FDA is evaluating the need for regulatory action. Certain amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate and dextroamphetamine sulfate (generic product) Lack of efficacy/effect FDA is evaluating the need for regulatory action.
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January - March 2021 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)

| U.S. Food and Drug Administration (FDA)
Addyi (flibanserin) Drug hypersensitivity The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include hypersensitivity reactions.
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July – September 2015 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)

| U.S. Food and Drug Administration (FDA)
Articaine hydrochloride (HCl)/epinephrine bitartrate injection Orabloc (articaine HCl/epinephrine bitartrate) injection Septocaine (articaine HCl/epinephrine bitartrate) injection, solution Paresthesia and taste disturbances FDA has determined that the last approved labeling for all local anesthetics used for dental procedures is adequately labeled for dental adverse events, including paresthesia and taste disturbances, and that no further regulatory action was needed at the time.
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April – June 2015 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)

| U.S. Food and Drug Administration (FDA)
Acetaminophen Pediatric ingestion errors Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen_Final Guidance (8/4/15) Bloxiverz (neostigmine methylsulfate) injection Vazculep (phenylephrine HCl) injection Potential product selection errors Carton and vial labeling designs were revised to better differentiate Vazculep from Bloxiverz.
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U.S. Food and Drug Administration (FDA) Journalists

Bernstein, Jessica

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