This webinar explores how collaborative-initiated trials and Investigator-Initiated Trials (IITs) are complementing traditional drug development to accelerate innovation, advance precision medicine, ...

OSE Immunotherapeutics has kicked off a strategic realignment initiative that involves deprioritizing the AbbVie-partnered OSE-230 and focusing its resources on the late-stage development of its ...

The FDA last October paused Intellia Therapeutics’ late-stage CRISPR studies after detecting life-threatening enzyme ...

In a complete response letter published by the FDA on Monday, the agency said a resubmission for REGENXBIO’s Hunter syndrome ...

Here’s how drug developers can best approach interactions with the agency following last year’s seismic changes to its leadership, workforce and policies.

Infrastructure and location have helped make Holly Springs a future hub for obesity drug production, with Amgen and Roche ...

FDA decisions lack majority consensus, experts agree, possibly leading to less nuanced verdicts on new drug applications.

Less than a year after cutting roughly 30% of its employees, BioAtla is letting go of an even larger chunk of its workforce as it considers its future, which could include strategic partnerships and ...

Days after FDA Commissioner Marty Makary appeared to malign uniQure’s AMT-130 in an interview with CNBC, the agency confirmed ...

As Novo Nordisk continues to lose ground in the obesity market to rival Eli Lilly, the Danish company has started construction projects to establish the ex-Alkermes plant as a hub for supplying oral ...

Aardvark Therapeutics is down 54% since Friday after the biotech said it detected “reversible cardiac observations” in a healthy volunteer study of its drug to treat extreme hunger in patients with ...

Yuviwel will compete with BioMarin’s Voxzogo. Meanwhile, BridgeBio is working to bring its own achondroplasia drug, the FGFR3 blocker infigratinib, to the market.