Articles

Inflation Reduction Act Pharmaceutical Impact: What You Need to Know

Learn about the Inflation Reduction Act's effects on pharmaceutical pricing, focusing on key medications like insulin and cancer therapies for Medicare patients.

ANVISA Clinical Trial Changes Brazil: What You Need to Know

Learn about the recent changes to ANVISA's clinical trial regulations in Brazil and how they impact drug development for various medical indications.

ANVISA Regulatory Changes: Key Impact on Foreign Drug Manufacturers in Brazil

ANVISA's recent regulatory changes significantly affect foreign drug manufacturers in Brazil, influencing drug approvals and market strategies for key treatments.

SAHPRA Accelerated Approval: What You Need to Know About Oncology Access

Learn how SAHPRA's Accelerated Approval is transforming oncology access, expediting vital treatments like Pembrolizumab for cancer patients in need.

African Medicines Agency impact: Harmonizing Clinical Trials in Africa

The African Medicines Agency is transforming clinical trials in Africa, streamlining processes for drug approvals and improving access to essential medicines.

Local Pharmaceutical Manufacturing South Africa: SAHPRA Policy Impact 2025

This article examines the implications of SAHPRA's 2025 policies on local pharmaceutical manufacturing in South Africa, focusing on drug accessibility and innovation.

FDA Accelerated Approval Pathway: Impact on Oncology Market Access & Pricing in 2026

This article examines how the FDA's Accelerated Approval Pathway will shape oncology market access and pricing strategies for cancer therapies in 2026.

FDA Guidance on Oncology Drugs: New Rules for Accelerated Approval

The FDA's new guidance on oncology drugs outlines updated rules for accelerated approval, impacting treatments such as Pembrolizumab for various cancers.

ANVISA Approves New Cannabis Framework & MagicTouch Device: Market Impact

The recent ANVISA approval of a new cannabis framework and the MagicTouch device marks a significant advancement in pain management solutions in Brazil.

COFEPRIS Drug Approvals 2026: What You Need to Know

Stay informed about COFEPRIS drug approvals in 2026, featuring essential insights on innovative treatments for diabetes and hypertension.

ANVISA Clinical Trial Regulations: What Foreign Pharma Must Know in 2025

Learn essential insights on ANVISA's clinical trial regulations for 2025, crucial for foreign pharmaceutical companies navigating drug approvals in Brazil.

Decentralized Clinical Trials in LATAM: Growth, Challenges & Regulatory Insights

This article delves into the rise of decentralized clinical trials in LATAM, highlighting key growth factors, challenges faced, and essential regulatory insights.

COFEPRIS Approval Pathway: Insights on Novel Immunotherapies for Advanced Melanoma

This article delves into the COFEPRIS approval process for innovative immunotherapies targeting advanced melanoma, highlighting key insights and drug developments.

Biosimilars Growth in Brazil: Market Potential Post-ANVISA Regulatory Updates

This article delves into the market potential for biosimilars in Brazil following recent ANVISA regulatory updates, highlighting Infliximab's role in treating autoimmune conditions.

ANVISA Regulatory Changes: Impact on Fast-Track Approvals for Oncology Drugs

This article examines how recent ANVISA regulatory changes affect the fast-track approval process for oncology drugs, enhancing patient access to treatments.

HIV Treatment Clinical Trials Africa: Long-Acting Injectables & AMA Pathways

This article delves into HIV treatment clinical trials in Africa, highlighting long-acting injectables and the AMA pathways for enhanced patient care.

Cancer Immunotherapies UAE: Regulatory and Access Insights 2025

This article provides essential insights into the regulatory landscape and access to cancer immunotherapies in the UAE, focusing on key drugs and future trends.

Plozasiran TGA Approval: REDEMPLO® Expands FCS Access in Australia

Arrowhead Pharmaceuticals has secured TGA approval for REDEMPLO® (plozasiran) in Australia, marking a significant step in providing a new treatment option for patients with Familial Chylomicronemia Syndrome (FCS). This approval broadens global access to plozasiran for this rare genetic disorder.

Mounjaro FDA Approval: Eli Lilly's Tirzepatide Milestone

Eli Lilly's tirzepatide, marketed as Mounjaro, has achieved FDA approval, marking a significant regulatory milestone. This dual GIP and GLP-1 receptor agonist is now more accessible for type 2 diabetes treatment in the US.

Mounjaro FDA Approval Obesity: Eli Lilly's Tirzepatide Awaits

Eli Lilly's Mounjaro (tirzepatide) is poised for a significant label expansion, seeking FDA approval for obesity and cardiovascular risk reduction. This potential approval could reshape the weight management and cardiovascular health markets.