The biopharma industry is accustomed to competing for capital, technology and promising assets. Increasingly, however, one of its most important constraints is human: securing the scientists, ...

The company announced positive data from a Phase III trial evaluating the safety and immunogenicity of VAX-31, a ...

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include five new products, one ...

CBER Director Karim Mikhail offered his view of the ideal candidate for Office of Therapeutic Products director and described his role as the conductor of an orchestra.

The US FDA's request for information on ibogaine envisions a fully equipped cardiology inpatient setting for early trials of ...

The FDA plans rulemaking allowing disclosure of NDA, BLA, and ANDA filing, something it cannot acknowledge now, as part of ...

Lupin has secured tentative FDA approval for apixaban oral suspension by filing a Paragraph III certification and will target ...

It remains difficult to raise VC cash for early-stage drug development or big manufacturing needs. While Varda raised a $251m ...

Teva has named a new CEO for its TAPI active ingredients business. Meanwhile, Hikma, Sandoz and Stada have announced new ...

The director general of the Spanish biotechnology industry association AseBio, Ion Arocena, spoke to Scrip about how Spain the country couldan position itself to be a key global biotech player.

A UK ruling that Eli Lilly breached industry Code of Practice for a press release and new Australian guidance on media coverage for medicines underscore how media engagement could breach drug ...

TL1A inhibition is a competitive area of R&D. Merck has the lead in IBD with tulisokibart, and new Phase II data support a ...