After losing its powerhouse partner, IGM Biosciences closed “most” of its labs and offices and initiated a strategic review ...

The FDA expects to fully integrate its AI approach by June 30, though its different centers have been instructed to start the ...

In a recent BioSpace LinkedIn poll, nearly half of respondents predicted the job market won’t turn around until 2027 or later ...

The missed PDUFA adds to a string of delays at the FDA in recent weeks, including at least two other missed target action ...

With President Donald Trump expected to deliver a drug pricing order on Monday that Big Pharma and patient groups alike have ...

Peter Marks, the venerable head of the FDA’s Center for Biologics Evaluation and Research, has been forced out. In this ...

The company discontinued development last month of its most mature asset, RLYB212, following disappointing mid-stage ...

Insitro’s layoffs affect about 65 employees as the AI-focused biotech looks to advance its pipeline in metabolic disease and ...

Takeda’s Julie Kim argues that Trump’s idea to match drug prices to that of other countries could cost the industry up to $1 ...

The cell engineering company, co-founded by oncologist and writer Siddhartha Mukherjee, does not see a path forward for its ...

Following a similar decision in case the trade group Outsourcing Facilities Association brought against FDA over its decision ...

After more than a month of speculation over how the FDA will rule on Novavax’s application for an updated formulation of its ...