Regulation

Pharmaceutical Regulation Sci&Tech

VEPPANU A Breakthrough of PROTAC

The drug ARV-471, now known by its generic name vepdegestrant and brand name VEPPANU, has made history. As of May 1, 2026, it became the first-ever PROTAC (Proteolysis-Targeting Chimera) to receive FDA approval. Discovered through the pioneering work at Arvinas and detailed in...

Industry Pharmaceutical Regulation

Learn the keypoint in two minutes: General Considerations for the Use of New Approach Methodologies in Drug Development

The central objective of the FDA’s draft guidance is to establish a rigorous validation framework, ensuring that New Approach Methodologies (NAMs) are reliable and fit-for-purpose for specific regulatory decisions. While “qualification” evaluates a tool’s general utility, validation...

Biotech Pharmaceutical Regulation

Top CMC Pitfalls in Biologics IND Application and How to Avoid Them

Filing an Investigational New Drug (IND) application for a biologic—be it a monoclonal antibody, recombinant protein, or vaccine—is a high-stakes milestone. While the Chemistry, Manufacturing, and Controls (CMC) section is critical, many applications face delays due...

Industry Pharmaceutical Regulation Sci&Tech

PBPK Modeling -The Computational Engine Driving Modern Drug Safety

The pharmaceutical industry is undergoing a paradigm shift, moving towards New Approach Methodologies (NAMs) to reduce reliance on traditional animal models. At the forefront of this shift is Physiologically Based Pharmacokinetic (PBPK) modeling, a mechanism-driven computational approach...

Biotech Industry Pharmaceutical Regulation

List of 2025 FDA New Drug Approvals

In 2025， FDA granted 44 novel drug approvals。This list summarizes the landmark novel therapeutic approvals, categorized by molecular modality and therapeutic area. Drug Name (Active Ingredient) Modality Company Indication Mechanism of Action (MoA) Key Highlights Journavx (Suzetrigine) Small Molecule Vertex...

Industry Regulation Sci&Tech

Comparative Summary of QSAR Platforms

This table provides a high-level comparison of the five key in silico tools based on their methodology, pros, cons, cost, and regulatory standing. Tool Primary Mechanism Key Advantage Key Disadvantage Regulatory Acceptance Cost/Access DEREK Nexus Rule-Based Expert System...

Chemical GLP Pharmaceutical Regulation Sci&Tech

New Approach Methodologies for Chemical Safety Assessment

Within fields like toxicology and drug development, embracing New Approach Methodologies (NAMs) is no longer optional but crucial for professionals seeking to remain at the forefront of their disciplines. Understanding and applying these innovative, human-relevant techniques...

Chemical Industry Pharmaceutical Regulation

The Ames Test: Unraveling Mutagenic Potential

The Ames test, a cornerstone of genetic toxicology, serves as a crucial tool for identifying potential mutagens and carcinogens. Several regulatory guidelines govern the conduct and interpretation of Ames tests, including OECD Test Guideline 471: This guideline provides...

Pharmaceutical Regulation Sci&Tech

ADME Testing: Your Drug’s Journey

Intro Why ADME? In Vitro vs. In Vivo ADME: The Breakdown For a deep dive into the details, you can continue reading for the next 3 minutes. The journey of a drug from the lab to the pharmacy...

Pharmaceutical Regulation Sci&Tech

Implement New Approach Methodologies (NAMs) in Drug Development

The landscape of drug development is evolving, with a growing emphasis on reducing and replacing animal testing. New Approach Methodologies (NAMs) are at the forefront of this shift, offering innovative, non-animal methods to assess drug safety...