United States — Food and Drug Administration & Abbott Laboratories
13 shared events · Importance 4 · Last updated Jun 24, 2026
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Regulatory
United States — Food and Drug Administration: The United States — Food and Drug Administration granted 510(k) clearance for the Diazyme Lipoprotein(a) Molarity Assay, enabling its use in clinical laboratories.
Abbott Laboratories: Abbott Laboratories, Inc. received 510(k) clearance from the United States — Food and Drug Administration for its Lipoprotein(a) Molarity Assay, which is a significant step forward for the company in cardiovascular risk assessment.
Jun 18, 2026 · 6 articles
Regulatory
United States — Food and Drug Administration: The FDA approved SimpleScreen CRC, adding a new blood-based screening option for colorectal cancer.
Abbott Laboratories: Abbott will exclusively commercialize SimpleScreen CRC, expanding its colorectal cancer screening portfolio alongside Cologuard, and leveraging its existing infrastructure.
Jul 27, 2026 · 6 articles
Business
United States — Food and Drug Administration: The United States — Food and Drug Administration is currently reviewing Abbott's dual glucose-ketone system, and its clearance is necessary for commercialization in the United States.
Abbott Laboratories: Abbott is collaborating with Medtronic — Medtronic MiniMed to commercialize its dual glucose-ketone sensors, expanding its reach in diabetes technology and potentially increasing revenue from its medical device segment.
Jun 03, 2026 · 7 articles
Business
United States — Food and Drug Administration: The new facility will be built to USFDA standards, ensuring regulatory compliance for the US market, which is critical for the partnership's success.
Abbott Laboratories: Neuland gains dedicated sterile API manufacturing capacity through Gland Pharma, supporting its growing demand and enhancing its CDMO capabilities. The corporate guarantee of ₹40 crore reflects its commitment.
Aug 05, 2026 · 6 articles
Business
United States — Food and Drug Administration: The FDA, along with other agencies, issued a statement that there is no conclusive evidence that preterm formula causes NEC, which supports the companies' defense.
Abbott Laboratories: Abbott is the primary defendant, agreeing to pay $670 million to settle part of the NEC litigation. The settlement reduces legal uncertainty but does not resolve all claims, and the company continues to face thousands of lawsuits.
Aug 20, 2026 · 20 articles
Business
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> (FDA) is the regulatory body reviewing Alvogen's resubmitted applications for AVT05 and AVT06. Their decision will determine the market entry of these biosimilars in the United States>>>.
Abbott Laboratories: Abbott Laboratories>>> is partnered with Alvogen>>> for AVT03, a different biosimilar. While not directly involved in the current resubmissions, their partnership with Alvogen>>> indicates a broader strategy in the biosimilar market.
Jun 04, 2026 · 10 articles
Business
United States — Food and Drug Administration: Carolina Liquid Chemistries Corporation is an FDA registered manufacturer, indicating its compliance with regulatory standards.
Abbott Laboratories: Abbott Laboratories acquired Carolina Liquid Chemistries Corporation, expanding its diagnostic capabilities and product offerings. This acquisition is expected to create synergies and benefit laboratories of all sizes.
Jun 01, 2026 · 7 articles
Regulatory
Abbott Laboratories: Abbott Laboratories is mentioned in the context of a previous infant formula recall in 2022, which caused a national shortage, providing a comparison point for the current ByHeart recall.
Nov 09, 2025 · 33 articles
Regulatory
Abbott Laboratories: Abbott Laboratories, through its Abbott Diabetes Care division, is at the center of this event due to the recall of its FreeStyle Libre 3 and FreeStyle Libre 3 Plus glucose monitor sensors. The malfunction has led to serious injuries and deaths, negatively impacting the company's reputation and potentially its stock price.
Dec 03, 2025 · 6 articles
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