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Vamorolone

New Drug Approvals

7 (2021) 13. [70] 7 (2021) 13 Chemistry Vamorolone is a synthetic corticosteroid and is also known by the chemical name 17α,21-dihydroxy-16α-methylpregna-1,4,9(11)-triene-3,20-dione or as 16α-methyl-9,11-dehydroprednisolone. . Goemans, S. Mercuri, A. Aartsma-Rus, Duchenne muscular dystrophy, Nat. Guglieri, P.R. Clemens, S.J.

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Landiolol

New Drug Approvals

“Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics. 28 October 2021. February 2021). . ^ Atarashi H, Kuruma A, Yashima M, Saitoh H, Ino T, Endoh Y, et al. August 2000). 68 (2): 14350. 2000.108733.

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Eplontersen

New Drug Approvals

“Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. World Health Organization (2021). 88 (12): 5389–5398. doi : 10.1111/bcp.15468. PMID 35869634. 22 December 2023. hdl : 10665/340684.

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TLC Provides Corporate Update at Investor Conference – Dec 18, 2020

The Pharma Data

With experiences attained in licensing and business development functions from Amgen, Baxter and Johnson & Johnson, Mr. Bliss introduced himself in Mandarin Chinese. In its Phase II clinical trial, TLC599 significantly reduced pain at and through every scheduled visit through six months. SOUTH SAN FRANCISCO, Calif.

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Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA. Read the AgencyIQ analysis here.

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

Agency IQ

0910-AI26 September 2023 March 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

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

Agency IQ

In 2022 and 2021, the Spring Unified Agenda was released in early/mid June. That means we could see an updated agenda in late June or early July, giving us a better sense of what FDA is working on and when it hopes to complete its rulemaking. The following PDUFA dates were obtained from publicly available sources.

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