Advarra

AUGUST 16, 2022

That is part of the responsibility of the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). Department for Health and Human Services (DHHS), prepared guidance on expedited programs for sponsors of orphan drug trials. These centers, in conjunction with the FDA and U.S.

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New Drug Approvals

APRIL 30, 2025

New Drug Therapy Approvals 2024 (PDF). Food and Drug Administration (FDA) (Report). Retrieved 21 January 2025. ^ “Novel Drug Approvals for 2024” U.S. 1] [2] Levacetylleucine is a modified version of the amino acid leucine. [1] 1] It is the L -form of acetylleucine. . ^ “IntraBio Announces U.S.

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PPD

MARCH 28, 2024

The biotech industry has long been at the forefront of innovation, revolutionizing health care and delivering breakthrough therapies to patients around the world. Furthermore, partnering with a CRO can bend the cost and time curve of drug trials, a critical factor for investors seeking returns on their capital.

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Agency IQ

MAY 3, 2024

Two consultations on clinical trial considerations, one on advanced therapies and the other addressing non-inferiority and equivalence comparisons, are closing at the end of May. The pharma reform package remains in E.U. leaders’ eyesight as the Parliament winds down ahead of its June elections. .:

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The Pharma Data

DECEMBER 8, 2020

The FDA has issued a clinical hold on Bellicum Pharmaceuticals for its ongoing phase 1/2 trial evaluating CAR-T therapy BPX-601 in patients who received prior treatment for metastatic pancreatic or prostate cancer, following the death of a trial participant. The Houston, Tex.,

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The Pharma Data

NOVEMBER 10, 2020

This is encouraging as a pharmacodynamic biomarker in larger trials,” Dage said. The assay is being explored for applications in clinical research, including new drug trials, based on its capability to identify patients with Alzheimer’s disease and also to predict their risk of progression. Source link.

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Advarra

JUNE 27, 2023

A clinical trial investigating a drug or therapy is typically divided into four phases: Phase I, Phase II, Phase III, and Phase IV. This article explores how the clinical research phases protect study volunteers from harm and ensure new drugs and therapies are developed effectively.

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Agency IQ

MARCH 29, 2024

Andrews, Oxford, the British Medical Journal Medicine products pending European Commission decision following CHMP opinion Below are the drug or biologic products for which decisions are expected to occur within the next two months, according to AgencyIQ’s review of opinions from the EMA’s Committee for Medicinal Products for Human Use (CHMP).

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Drug Target Review

NOVEMBER 30, 2023

We are the only company in the world including this population in any Alzheimer’s drug trial, and we are very proud of this! Our investigational active immunisation therapies could potentially delay or perhaps even prevent the onset of clinical dementia symptoms. COVID-19 has shown the revolutionary impact of vaccines.

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Codon

MARCH 14, 2023

For every 5,000 drug compounds tested in mice, five move into human studies. The ALS Therapy Development Institute, located just ten minutes from my home in Cambridge, once tested more than 100 potential drugs to slow ALS progression in mice, all of which had been reported to be helpful in other studies. .”

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Codon

JANUARY 21, 2024

We wouldn't do a challenge trial for Ebola, because the disease is extremely severe, and there are currently no licensed treatments or vaccines. You can do a challenge trial with deadly diseases, but you need a “rescue therapy.” There have been deaths in phase 1 medical and drug research among healthy participants.

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New Drug Approvals

MAY 23, 2025

The combination therapy sulbactam/durlobactam was approved for medical use in the United States in May 2023. [1] Durlobactam CAS 1467829-71-5 WeightAverage: 277.25 OCT-3-EN-6-YL SULFATE SULFURIC ACID, MONO((2S,5R)-2-(AMINOCARBONYL)-3-METHYL-7-OXO-1,6-DIAZABICYCLO(3.2.1)OCT-3-EN-6-YL)

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New Drug Approvals

MAY 20, 2025

New Drug Therapy Approvals 2023 (PDF). Food and Drug Administration (FDA) (Report). Bausch + Lomb Corporation. 18 May 2023. Retrieved 8 June 2023 via Business Wire. ^ January 2024. Archived from the original on 10 January 2024. Retrieved 9 January 2024.

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New Drug Approvals

MAY 14, 2025

“Salvage therapy of complicated Candida albicans spondylodiscitis with Rezafungin” European Journal of Clinical Microbiology & Infectious Diseases. “Salvage Therapy with Rezafungin for Candida parapsilosis Spondylodiscitis: A Case Report from Expanded Access Program” Microorganisms. 2] [3] CAS No.

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New Drug Approvals

APRIL 13, 2025

Olezarsen FDA APPROVED 12/19/2024, Tryngolza , To treat familial chylomicronemia syndrome Drug Trials Snapshot Synonyms AKCEA-APOCIII-LRX ALL-P-AMBO-5′-O-(((6-(5-((TRIS(3-(6-(2-ACETAMIDO-2-DEOXY-.BETA.-D-GALACTOPYRANOSYLOXY)HEXYLAMINO)-3-OXOPROPOXYMETHYL))METHYL)AMINO-5-OXOPENTANAMIDO)HEXYL))PHOSPHO)-2′-O-(2-METHOXYETHYL)-P-THIOADENYLYL-(3′-O->5′-O)-2′-O-(2-METHOXYETHYL)-P-THIOGUANYLYL-(3

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New Drug Approvals

MAY 26, 2025

“Flotufolastat F 18: Diagnostic First Approval” Molecular Diagnosis & Therapy. External links Clinical trial number NCT04186819 for “Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) Flotufolastat F 18 Flotufolastat F-18 Gallium POSLUMA CAS 2305081-64-3 18FrhPSMA-7.3

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New Drug Approvals

APRIL 22, 2025

R*)))- FDA APPROVED sulopenem etzadroxil, probenecid, 10/25/2024, To treat uncomplicated urinary tract infections (uUTI) Drug Trial Snapshot Sulopenem ( CP-70,429 ) is a thiopenem antibiotic derivative from the penem family, which unlike most related drugs is orally active. 10 (4): 18151835. doi : 10.1007/s40121-021-00509-4.

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New Drug Approvals

MAY 11, 2025

3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [9] Jump up to: a b New Drug Therapy Approvals 2023 (PDF). Food and Drug Administration (FDA) (Report). 2] [5] It is taken by mouth. [2] 9] SYNTHESIS PATENT Sheikh, AY et al. 23 (2): 775777. doi : 10.1007/s12311-023-01568-8.

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Drug Target Review

APRIL 25, 2025

15 In addition to detecting hepatotoxicity and renal toxicity, complex in vitro models in high-throughput 384 well-plate format cultured under perfusion flow can be utilised for detecting drug-induced disruption of the gut epithelium barrier. link] [19] Safarzadeh M, Richardson LS, Kammala AK, et al. Extracellular Vesicle 3 (2024) 100035.

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New Drug Approvals

MAY 30, 2025

1] [7] [8] [9] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [10] New Drug Therapy Approvals 2023. Food and Drug Administration (FDA) (Report). Lotilaner CAS 1369852-71-0 Credelio XDEMVY lotilanerum 596.8 1] [7] It is used as an eye drop. [1] Tarsus Pharmaceuticals.

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New Drug Approvals

APRIL 27, 2025

octane-8,1′-azolidin-1-ium]-3-yl 2-hydroxy-2,2-diphenylacetate;chloride FDA 2024, Cobenfy 9/26/2024, To treat schizophrenia Press Release Drug Trials Snapshot Trospium chloride is a muscarinic antagonist used to treat overactive bladder. [3] decane chloride 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-8lambda5-azaspiro[bicyclo[3.2.1]octane-8,1′-pyrrolidin]-8-yliumchloride

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FDA Approval FDA Pharmacokinetics Licensing 57

New Drug Approvals

APRIL 21, 2025

New Drug Therapy Approvals 2024 (PDF). Food and Drug Administration (FDA) (Report). Acoramidis AG-10 1446711-81-4 AG10 Acorami 292.30 Retrieved 20 December 2024. ^ “FDA approves BridgeBio Pharma’s Attruby to treat rare heart disease ATTR-CM” PMLiVE. 25 November 2024. Retrieved 25 November 2024. ^ January 2025.

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