Our Pharma Insights Blog

July 2026 FDA Approvals: 6 New Drugs With Billion-Dollar Potential

6 new drugs were approved by the FDA in the month of July. These drugs…

Understanding Controlled Clinical Trials: Design, Comparators and the Supply Chain Behind the Data

A drug can look brilliant in a single-arm study and fail completely once placed head-to-head…

OGSIVEO®: Market Intelligence Insights on A High-Value Oncology Opportunity

High-value oncology drugs often come with equally complex clinical supply requirements. OGSIVEO® (nirogacestat) is one…

FDA Rolling Review Process Explained: How It Works

Every few months, someone in a regulatory affairs forum asks a version of the same…

The Ancillary Problem in Speciality Sourcing: A Market-Intelligence Look at Fintepla® (fenfluramine)

In specialty and comparator sourcing, the working assumption is that the molecule is the hard…

June 2026 FDA Approvals: Exclusivity Timelines and Comparator Sourcing

The clock on exclusivity doesn’t start when a patent expires; it starts the moment a…

The Paragraph IV Race for ORSERDU®: Navigating the Clinical Supply Bottleneck

The NCE-1 date for 𝗢𝗥𝗦𝗘𝗥𝗗𝗨® (𝗘𝗹𝗮𝗰𝗲𝘀𝘁𝗿𝗮𝗻𝘁) is January 27, 2027. While patent protection may extend…

May 2026 FDA Approvals: Market Trajectories and Clinical Supply Implications

When a new therapy enters the market, it frequently shifts the baseline standard of care,…

April 2026 FDA Approvals: What Foundayo and Idvynso Mean for Generic Drug Developers

The FDA approvals in April 2026 introduced two important drugs that could create major opportunities.…

What Are Biologics? Types, Uses, Side Effects and Biosimilars

From vaccines to cancer therapy, biologics are transforming how we treat disease. They don’t just…

New FDA Drug Approvals of March 2026: 5 Drugs Shaping Para IV & aBLA Strategies

The FDA approved 5 drugs in March 2026. The approved drugs span across fields like…

February 2026: 4 High-Impact FDA Drug Approvals You Need to Know

With 1 drug approved in January 2026, we saw a great hike in the approval…

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