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.

American Injectables plans to build up its US-based manufacturing after securing a commitment for $10m of ‘Series A’ financing from New Rhein Healthcare Investors, which it will use to scale up production and launch several generic parenteral products.