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Big Pharma Companies Have Higher US FDA Approval Percentage Than Everybody Else

 
• By Bridget Silverman

Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a recent analysis of FDA approval decisions since 2021.

FDA Approved typed words on a vintage typewriter

A beneficial effect of sponsorship by the largest companies in the pharma industry can be seen in the fates of novel agent applications that faced US FDA approval decisions in recent years: the applications associated with big pharma were approved at a higher rate than novel agent NDAs and BLAs attached to mid-sized and small firms, an analysis of Pink Sheet’s US FDA Performance Tracker shows.

A little more than one-quarter of the FDA’s decisions on novel agent applications with user fee goal dates in 2021,...

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Strategic Surprises: The Drugs That Rewrote The Forecasts

 
• By Edwin Elmhirst

Many assets do not meet their pre-launch predictions, either exceeding or falling short of their forecast sales. In this article, In Vivo highlights several historic examples and the factors that influenced their unexpected performance.

AI In Biologics Discovery: The Expensive Bet On Unproven Promise

 
• By David Wild

Despite limited evidence of commercial impact, pharmaceutical companies are making massive strategic investments in AI biologics platforms. The question isn't whether the technology shows promise; it's whether that promise can translate to measurable business results.

BioBytes: AI-Related Deals In Q2 ‘25

 
• By David Wild

When it came to AI-related deals, the second quarter of 2025 was characterized by mostly modest financings.

Titans Of Pharma: Lilly’s Ricks Tops Big Pharma Pay Chart

 
• By Eleanor Malone, Edwin Elmhirst, and Kosh Naran

The big pharma CEO with the highest-valued compensation in 2024 was David Ricks of Eli Lilly, while Pfizer and J&J executives slipped into third and fourth place behind AbbVie's now retired chief Richard Gonzalez. European firms brought up the rear.

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Deals In Depth: June 2025

 
• By Deanna Kamienski and Maureen Riordan

Five $1bn+ alliances were penned in June, and four exceeded $2bn.

Global Pharma Interest In Korea Undeterred Despite Political Roller Coaster

 
• By Jung Won Shin

Despite recent political turmoil, outside investor and corporate interest in South Korean biopharma innovation appears robust or even increasing.

Podcast: Oxolife’s Agnés Arbat, Winner Of The European Prize For Women Innovators

 
• By Jo Shorthouse

Agnès Arbat, CEO of Oxolife and winner of the EU Women Innovators Prize, joins In Vivo to discuss OXO-001, a novel non-hormonal treatment aimed at improving embryo implantation in IVF. She shares insights from her biotech journey and the future of fertility innovation.