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Elacestrant 

New Drug Approvals

1] [8] Pharmacokinetics Elacestrant has an oral bioavailability of approximately 10%. [1] Lloyd MR, Wander SA, Hamilton E, Razavi P, Bardia A (2022). 1] Additionally, elacestrant is a selective estrogen receptor degrader (SERD), meaning it induces the degradation of ER. [1] 21 September 2023. Retrieved 22 September 2023.

FDA 62
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Eplontersen

New Drug Approvals

December 2022). “Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. . | Facebook Twitter FACEBOOK join me on twitter Anthony Melvin Crasto Dr. | twitter +919321316780 call whatsaapp EMAIL.

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Steep FY2025 PDUFA Fee Increase: Ways to Reduce the Full Fee Rate for Repurposed Drugs

The Premier Consulting Blog

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees. patients with renal, hepatic, or cardiovascular concerns).

Drugs 52
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Etrasimod

New Drug Approvals

July 2022). . | twitter +919321316780 call whatsaapp EMAIL. “Velsipity (etrasimod) tablets, for oral use” (PDF). . “Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies” Lancet. 401 (10383): 1159–1171. PMID 36871574. ^

FDA 57
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Crinecerfont

New Drug Approvals

1 November 2022). 17 February 2022). . “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82” WHO Drug Information. hdl : 10665/330879. Further reading Auchus, Richard; Chan, Jean; Farber, Robert; Fechner, Patricia; Giri, Nagdeep; Nokoff, Natalie; et al. (1 6 (Supplement_1): A618.

FDA 62
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Landiolol

New Drug Approvals

21 December 2022. “Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics. 24 August 2022. Further reading Shiga T (June 2022). . ^ “Details for: Sibboran” Health Canada. 20 November 2023.

FDA 62
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Concert Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Company Update

The Pharma Data

The Company expects to report topline results from the THRIVE-AA1 trial in 2022. License and research and development revenue. The initiation of the THRIVE-AA1 trial follows an end-of-phase 2 meeting where Concert discussed key aspects of its Phase 3 program and registration strategy with the FDA.