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Your First Drug's Approved and Launched...Now What?

 
• By Alex Lash

FDA new drug approvals are making a comeback, and a group of biopharma first-timers are leading the way. To understand the challenges they face in the transition from discovery to commercialization, IN VIVO looked at 50 companies spanning the past 10 years. Finally reaching the US market might be a biotech's defining moment, but for those who build to last, there could be more rewards beyond that first approval.

As product approvals at the Food and Drug Administration rebound from the ebb tide of late last decade, a striking number of first-timers have recently joined the ranks of approved drug sellers. Since the start of 2010 ten firms have gotten their first FDA approvals, including such high-profile names as Human Genome Sciences Inc. and Dendreon Corp., and several more are lined up. (See Exhibit 1.)

This "graduating class" represents a major shift in focus from research and development to commercialization, a crucial and difficult step...

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Podcast: “They Are Able To Keep Their Body”: Medipost On Its Stem Cell Therapy Vision

 
• By Anabel Costa-Ferreira

In Vivo spoke with Edward Ahn, CEO of Medipost, a Korean company that has developed stem cell therapies from cord blood, on how they are working across regulatory markets to provide a novel treatment for degenerative diseases.

Can Italy Shake Off Its Reputation And Become A Premier Hub For Biotech?

 
• By Barnaby Pickering

Leading industry experts have spoken to In Vivo about how investment, a change in mindset and a fresh approach to policy may allow Italy to kick-start its biotech ecosystem.

Rising Leaders 2025: Abbas Kazimi’s Vision For Nimbus Therapeutics

 
• By David Wild

Rising Leader Abbas Kazimi's leadership at Nimbus Therapeutics combines immigrant resilience, patient-first partnerships, contrarian strategic bets and a deeply personal mission driving breakthrough drug discovery innovation.

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.

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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.