Enforcement Report - Week of February 28, 2024
Enforcement Report - Week of January 24, 2024
Enforcement Report - Week of September 13, 2023
Enforcement Report - Week of July 26, 2023
Ascend Gene & Cell Therapies, a CDMO for AAV-based therapies, has emerged from stealth with $130 million in funding and plans to acquire experienced teams.
Enforcement Report - Week of April 26, 2023
Enforcement Report - Week of April 5, 2023
Ascend Laboratories, a unit of Indian drugmaker Alkem Laboratories, has issued a voluntary recall of 10 lots of the anticoagulant dabigatran etcxilate in capsule form after finding higher than acceptable levels of the suspected carcinogen N-nitroso-dabigatran during routine testing.
FOR IMMEDIATE RELEASE- Parsippany. New Jersey. Ascend Laboratories LLC. is voluntarily recalling Dabigatran Etcxilate Capsules. USP 75 mg and 150 mg to the consumer/user level due to the presence of a nitrosamine. N-nitroso-dabigatran, above the established Acceptable Daily Intake (ADI) level. To date, Ascend Laboratories LLC., has not received any reports of adverse events related to this recall.
Enforcement Report - Week of February 1, 2023