Trastuzumab pamirtecan, being developed under a 2023 partnership between BioNTech and DualityBio, elicited a 44.1% overall ...

Pivotal findings for the off-the-shelf cell therapy surpassed William Blair’s expectations and sent Allogene Therapeutics’ stock up more than 50% in pre-market trading Monday morning.

Almost half of the top 100 medicines vulnerable to supply disruptions in the U.S. have at least one key starting material ...

The licensing deal marks AbbVie’s first foray into new pain medicines, a space where Vertex currently enjoys a lead thanks to the NaV1.8 inhibitor Journavax.

BioSpace is the digital hub for life science news and jobs. We provide essential insights, opportunities and tools to connect innovative organizations and talented professionals who advance health and ...

In a difficult disease, Revolution Medicines achieved what the pancreatic cancer community has long desired: a significant improvement in survival. The Phase 3 results will support global regulatory ...

Principal Scientist Anders Cai Holm Hansen explains how CDMO AGC Biologics uses its global, single-use network and a strategy ...

Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more ...

Replimune’s CEO Sushil Patel has already warned that the biotech will need to cut staff and substantially scale back its U.S. manufacturing operations.

The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare ...

Novo Nordisk’s oral Wegovy has a few months’ head start on Eli Lilly’s newly approved pill. While the Indianapolis pharma has ...

The FDA in a complete response letter to Replimune maintained its original objection to the single-arm trial the biotech used ...