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Food and Drug Administration

Yummy Swirly Ices, various flavors
National

FDA Announces Recall of Yummy Swirly Ices Due to Potential Milk Contamination

August 8, 2024August 8, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration (FDA) has announced that Yummy Foods, based in Edison, NJ, is recalling its Yummy Swirly Ices line due to potential milk contamination. …

FDA Announces Recall of Yummy Swirly Ices Due to Potential Milk Contamination Read More

Heparin Sodium in 0.9% Sodium Chloride Injection
National

Baxter Recalls Heparin Sodium Injection Over Elevated Endotoxin Levels

August 8, 2024August 7, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration (FDA) announced that Baxter International Inc. (NYSE:BAX) is voluntarily recalling one lot of Heparin Sodium in 0.9% Sodium Chloride Injection due to …

Baxter Recalls Heparin Sodium Injection Over Elevated Endotoxin Levels Read More
Coconutmilk Chocolate Almond Crunch Frozen Dessert
National

FDA Issues Recall for Non-Dairy Frozen Dessert Due to Undeclared Allergen

August 7, 2024August 7, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration (FDA) has announced a recall by G.S. Gelato & Desserts, Inc. of a limited amount of Full Circle Market Coconutmilk Chocolate Almond Crunch …

FDA Issues Recall for Non-Dairy Frozen Dessert Due to Undeclared Allergen Read More

Ocugen
Products and Services

Ocugen Receives FDA Approval for Expanded Access Program for Retinitis Pigmentosa Treatment

August 7, 2024August 6, 2024 - by Timothy Alexander

MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) has received approval from the Food and Drug Administration to begin its expanded access program (EAP) for the treatment of adult patients with …

Ocugen Receives FDA Approval for Expanded Access Program for Retinitis Pigmentosa Treatment Read More
Food and Drug Administration
Regional

FDA Utilizes AI/ML for Drug Therapy Decision-Making

August 6, 2024August 4, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration (FDA) recently published a groundbreaking analysis on the use of artificial intelligence and machine learning (AI/ML) in drug therapy decisions. This marks …

FDA Utilizes AI/ML for Drug Therapy Decision-Making Read More

Bikano Moong Dal 350g
National

FDA Issues Recall for Bikano Moong Dal Over Salmonella Concerns

August 6, 2024August 6, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration (FDA) has announced a recall of 640 packs of “Bikano Moong Dal 350g” by Thal Golden Spices Inc. of Hayward, California. The …

FDA Issues Recall for Bikano Moong Dal Over Salmonella Concerns Read More
Woman feeding a baby
National

FDA Issues Safety Alert on Crecelac Infant Formula Due to Nutrient Imbalances and Bacterial Contamination

August 6, 2024August 6, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration (FDA) recently issued an urgent safety alert to warn consumers about the potential risks associated with Crecelac Infant Powdered Goat Milk Infant …

FDA Issues Safety Alert on Crecelac Infant Formula Due to Nutrient Imbalances and Bacterial Contamination Read More

Johnson & Johnson
Regional

FDA Approves DARZALEX FASPRO® for Newly Diagnosed Multiple Myeloma Patients

August 6, 2024August 5, 2024 - by Timothy Alexander

HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) recently approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and …

FDA Approves DARZALEX FASPRO® for Newly Diagnosed Multiple Myeloma Patients Read More
Food and Drug Administration
National

FDA Reviews Adverse Event Reports on Purina Pet Food

August 6, 2024August 4, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration (FDA) recently released a summary of adverse event reports (AERs) related to Purina pet food. Covering the period between November 22, 2023, and …

FDA Reviews Adverse Event Reports on Purina Pet Food Read More
Food and Drug Administration
National

FDA Announces Medical Device User Fees for Fiscal Year 2025

August 6, 2024August 4, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration (FDA) has issued a Federal Register notice detailing the medical device user fees and annual establishment registration fees for Fiscal Year 2025 …

FDA Announces Medical Device User Fees for Fiscal Year 2025 Read More

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