Remove 2025 Remove Clinical Pharmacology Remove Therapies
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Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

Alta Sciences

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.

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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. New Drug Therapy Approvals 2024 (PDF). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025.

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Altasciences’ Ophthalmic Expertise: A Conversation with Dr. Simone Iwabe, DVM, PhD, DACVO and Randy Wheeland, BS

Alta Sciences

Altasciences is a forward-thinking drug development solutions company providing pharmaceutical and biotechnology companies with a flexible approach to preclinical and clinical pharmacology studies. This article was posted in April 2025 Image Thumbnail_Blog_Simone and Randy.jpg Tags Preclinical Research Weight 15

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ATICAPRANT

New Drug Approvals

2] [3] [4] A regulatory application for approval of the medication is expected to be submitted by 2025. [2] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Pharmacology Pharmacodynamics Aticaprant is a potent , selective , short-acting (i.e., 2] Aticaprant is taken by mouth. [1]

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Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Agency IQ

Date What’s Happening Explanation Source June 29 GGP Report FDA expected to finalize report on Good Guidance Practices AgencyIQ June 30 User Fee Payments Industry required to confirm NDA prescription drug products in Orange Book for purposes of PDUFA payments in FY 2025 FDA July 1 Anniversary Anniversary of the signing of the Public Health Service (..)

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Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

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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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