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Landiolol

New Drug Approvals

Landiolol 133242-30-5 ONO-1101 Ono 1101 WHO 7516 FDA APPROVED 11/22/2024, Rapiblyk , To treat supraventricular tachycardia C25H39N3O8 509.6 “Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics.

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Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda. FDA has proposed to amend the 503A Bulks List by placing additional bulk drug substances on the list. Read our analysis of that rule here and here. ]

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Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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Iomeprol

New Drug Approvals

1] [2] [3] Iomeprol was approved for medical use in the United States in November 2024. [1] Food and Drug Administration (FDA). New Drug Therapy Approvals 2024 (PDF). Food and Drug Administration (FDA) (Report). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025.

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Acoramidis

New Drug Approvals

6] Acoramidis was approved for medical use in the United States in November 2024, [6] [7] [8] [9] and in the European Union in February 2025. [2] 18] Society and culture Legal status Acoramidis was approved for medical use in the United States in November 2024. [6] 6] [7] [19] The approval was granted to BridgeBio Pharma. [10]