Alta Sciences

FEBRUARY 19, 2025

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.

Drug Development 52

Drug Development Clinical Pharmacology Immune Response Drugs 52

New Drug Approvals

JULY 25, 2025

2025, 68, 2147−2182 Vamorolone (Agamree). “VBP15, a novel dissociative steroid compound, reduces NFκB-induced expression of inflammatory cytokines in vitro and symptoms of murine trinitrobenzene sulfonic acid-induced colitis” Inflammation Research. Retrieved 11 February 2025. Nagaraju, J.M. Damsker, J.M. 2018.09.007.

FDA 62

FDA FDA Approval Treatment Clinical Trials 62

Alta Sciences

APRIL 10, 2025

Altasciences is committed to using cutting-edge technology to support its ocular research. From comprehensive ocular assessments to complex surgical interventions, Altasciences is equipped to handle the full spectrum of ophthalmic research needs. What advanced instruments does Altasciences utilize to conduct these ocular studies?

Clinical Pharmacology 52

Clinical Pharmacology Drug Development Drugs Research 52

New Drug Approvals

SEPTEMBER 13, 2024

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., Progress in Brain Research.

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Agency IQ

JULY 8, 2024

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 (..)

FDA 40

FDA Science Regulations Production 40

Agency IQ

JUNE 16, 2023

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. Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation.

Regulations 40

Regulations FDA Science Production 40

Alta Sciences

JULY 31, 2024

How Improving Diversity Can Benefit Clinical Trials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025. Tags Clinical Trials Weight 15

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Drug Development 52