News

NMPA Drug Approvals Surge in 2025: Record 61 First Global Approvals Signal Accelerated Market Access

The National Medical Products Administration (NMPA) approved a record 61 drugs for first global approval in 2025, spanning modalities from small molecules to cell and gene therapies. New regulatory measures on contract manufacturing and pre-approval importation signal a more agile yet controlled approval environment for BD teams and investors.

A Decade of AI Medical Device Regulation: Key Updates for Pharma

This article reviews a decade of AI medical device regulation, highlighting key FDA and EMA updates from 2015 to 2025. It provides actionable insights for pharma business development and regulatory teams navigating the evolving compliance landscape.

Cell and Gene Therapy Approvals in China: Latest Regulatory Updates

China's NMPA has approved multiple cell and gene therapies in 2024, signaling a shift toward faster regulatory pathways. This article covers key approvals, implications for pharma teams, and an FAQ section.

Regulatory Round-Up: Key Drug Approvals on May 18, 2026

On May 18, 2026, the FDA and EMA announced several significant drug approvals, impacting therapeutic landscapes and competitive strategies. This round-up details the key decisions and their potential ramifications for the pharmaceutical industry.

Risen Pharma Initiates Phase 2 Trial for RP902 in Alzheimer's

Structured plan for Risen Pharma Initiates Phase 2 Trial for RP902 in Alzheimer's

Optical Coherence Tomography Gains Regulatory Traction in Pharma Filings

Recent regulatory updates have formally recognized Optical Coherence Tomography (OCT) as a valid analytical technique for pharmaceutical filings. This development promises to streamline drug development processes and offers significant implications for pharmaceutical business development teams, investors, and analysts.

Datroway Approved: A New Hope for Metastatic TNBC Patients

The FDA has approved Datroway, the first TROP2-directed antibody drug conjugate, for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC). This landmark approval offers a new therapeutic avenue for a challenging patient population.

Big Pharma's China Oncology Trials: Navigating a Landscape of Reduced Scrutiny

Big Pharma's oncology trials in China are operating with significantly less regulatory scrutiny than in Western markets. This shift presents both competitive advantages and potential risks for companies, impacting business development strategies and investment decisions.

PREMIA and Lind Launch Lind Asia to Revolutionize Clinical Trials with AI

Kissei Pharmaceutical Halts Tavneos Use Amid Deaths

Structured plan for Kissei Pharmaceutical Halts Tavneos Use Amid Deaths

PMDA Approves New Pharmaceuticals and Medical Devices: What's New

Japan's Pharmaceuticals and Medical Devices Agency (PMDA) continues to facilitate new drug approvals, contributing significantly to the nation's healthcare landscape. The agency offers robust support for medical product development through various consultations and scientific advice.

Global Regulatory Agencies Update Real-World Evidence Guidance for Decision-Making

Regulatory bodies worldwide are refining their guidance on the use of real-world evidence (RWE) to inform drug approval and post-market surveillance. This evolution presents new opportunities and challenges for pharmaceutical companies seeking to leverage RWE in their regulatory strategies.

China's Ascendancy in Oncology Research Alarms European Oncologists, Threatening Europe's Competitive Edge

European oncologists are raising alarms over China's rapid ascent in oncology research, with concerns that the nation is on the verge of overtaking Europe's established position. This shift, highlighted at major oncology conferences, signals a significant geopolitical realignment in scientific innovation and poses critical questions for the global pharmaceutical industry.

ASCO 2026: Asian Oncology Innovation Takes Center Stage, Driving Global Clinical Trial Advancements

ASCO 2026 emerged as a pivotal event for Asian oncology, showcasing significant advancements in clinical trials and first-in-class therapeutics. The conference underscored the growing leadership of companies from China, Japan, and South Korea, signaling a new era of global innovation.

BeOne Medicines' HERIZON-GEA Phase 3 Data in NEJM: A Deep Dive for Pharma BD and Investors

BeOne Medicines has announced the publication of its Phase 3 HERIZON-GEA trial data in The New England Journal of Medicine (NEJM). This development offers significant insights for pharmaceutical business development teams and investors evaluating the company's pipeline and market potential.

Newron Pharmaceuticals to Present at Upcoming Investor Conferences

Newron Pharmaceuticals is set to participate in significant investor conferences throughout June 2026. This presents an opportunity for analysts and BD teams to gain insights into the company's latest developments and future outlook.

Dishman Carbogen Amcis Shanghai Site Achieves NMPA GMP Compliance with Zero Findings

Dishman Carbogen Amcis' Shanghai site has achieved full compliance with China's National Medical Products Administration (NMPA) Good Manufacturing Practice (GMP) standards, evidenced by a recent audit with no observations. This successful inspection underscores the site's commitment to high-quality pharmaceutical manufacturing.

Hong Kong Overhauls Drug Approval Process: What Pharma BD Teams Need to Know

Hong Kong's drug regulatory authority is transitioning to an independent assessment model for new drug submissions, aiming to streamline the approval process. This strategic shift presents new opportunities and considerations for pharmaceutical companies operating in or targeting the region.

Estado Actual y Acciones para Impulsar la Investigación Clínica en México: 2025

Este artículo analiza el estado actual de la investigación clínica en México y las acciones necesarias para su impulso en 2025, destacando cambios regulatorios y oportunidades de inversión.

Pharmaceuticals Market Size and Share Analysis for 2034

The pharmaceutical market is poised for significant growth by 2034, driven by advancements in clinical trials. This article delves into market size, share, and implications for stakeholders.