In a joint statement, 1 the White House and the EU announced the details of what is being called a framework for an agreement ...

Regeneron Pharmaceuticals announced FDA extended review timelines to Q4 2025 for two regulatory submissions related to Eylea ...

The agreement values Mural Oncology at up to $36.2 million, with shareholders set to receive a base cash payment and ...

The collaboration will leverage Boehringer Ingelheim’s manufacturing expertise to accelerate AnGes’ HGF gene therapy toward ...

Darzalex Faspro's supply and availability remain unaffected, and no new clinical studies were requested by the FDA.

Rob Abbott, CEO, ISPOR, highlights how uniting regulators, payers, and academic leaders worldwide can accelerate access to ...

EMD Serono recently named Miguel Fernandez Alcalde as its new president. The new executive spoke with Pharmaceutical ...

The disease doesn’t have any FDA approved treatments, leaving families desperate for FDA to approve the treatment.

Pharm Exec unveils its new slate of rising leaders in the biopharma industry—profiling the stories of five executives ...

The clinical hold is due to questions about BX004’s nebulizer device, temporarily pausing US enrollment in the cystic ...

The regulatory body determined that PTC Therapeutics’ New Drug Application for vatiquinone did not provide sufficient ...

Novo Nordisk reduces Ozempic's price to $499/month for self-paying patients, enhancing access to essential diabetes treatment ...