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Vamorolone

New Drug Approvals

The distinction between it and traditional corticosteroid drugs lies in its capacity to specifically activate particular signaling pathways of corticosteroids. In individuals diagnosed with DMD, the primary mechanism through which corticosteroid drugs exhibit their effectiveness is by exerting anti-inflammatory effects. 70) Keam, S.

FDA
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FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

FDA Law Blog: Drug Discovery

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology. The draft guidance recommends that no more than 15 questions are included in the briefing package.

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Optimized 505(b)(1) and 505(b)(2) Clinical Pharmacology Programs to Accelerate Drug Development

The Premier Consulting Blog

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways.

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Shaping drug development success: how does artwork play a role?

Drug Target Review

This continued innovation highlights the complexity of the drug development process, particularly as the field is highly regulated by health authorities around the world. While it may not seem like a priority at first glance, the success of a drug can hinge on early decisions around artwork.

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Navigating the 505(b)(2) Pathway: No Two Drugs Are Alike

The Premier Consulting Blog

The 505(b)(2) new drug application (NDA) pathway offers a unique opportunity for small molecule developers to bring innovative products to market more efficiently by leveraging existing data they do not own or have right of reference to. The overall development strategy for GT123 was to include a complete CMC package.

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Altasciences Chosen by Virpax to Support the Development of a New Drug to Prevent Spread of Flu-like Viruses

Alta Sciences

Altasciences Chosen by Virpax to Support the Development of a New Drug to Prevent Spread of Flu-like Viruses pmjackson Wed, 09/20/2023 - 13:48 Laval, Québec, September 21, 2023 - Altasciences is pleased to have been chosen by Virpax Pharmaceuticals, Inc. Altasciences helps sponsors get better drugs to the people who need them, faster.

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Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder (MDD)

The Pharma Data

Nasdaq: BIIB) initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone in the treatment of major depressive disorder (MDD). Zuranolone is an investigational two-week, once-daily oral drug being developed for MDD and postpartum depression (PPD).