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Janssen reported positive topline data from a Phase II proof of concept study assessing nipocalimab in severe hemolytic disease of the fetus and newborn.
Biogen and its partner, Sage Therapeutics, announced the FDA has accepted the New Drug Application for zuranolone and granted it priority review in two mental health indications.
If you’ve recently lost your job, BioSpace has provided a guide to confidentiality agreements and severance packages so you can feel confident making your next career move.
Astellas named a new president and CEO and announced additional changes to its leadership structure in an effort to accelerate growth and chart its long-term business trajectory.
The FDA placed 4D Molecular Therapeutics’ gene therapy program, 4D-310, on clinical hold, the company announced Thursday.
The discovery of novel Alzheimer’s biomarkers is enabling better trial selection, earlier pipeline decision making and new targets for therapeutics.
Structure Therapeutics expects to bring in $161.1 million from an upsized IPO, announced Friday.
Sanofi is discontinuing its Phase III study of tolebrutinib, an investigational BTK inhibitor for myasthenia gravis.
Keytruda could be on its way to snagging another indication as a first-line therapy for endometrial cancer after the company announced positive Phase III results Friday.
Magenta Therapeutics is cutting about 84% of its workforce after a patient’s death halted a Phase I/II trial in acute myeloid leukemia.
Patient Square Capital announced a record-breaking inaugural fund totaling $3.9 billion, proving even in an unstable economy, there’s still money to be made.
Wednesday, the FDA approved GSK’s daprodustat, now to be marketed as Jesduvroq, for the treatment of anemia due to chronic kidney disease in adult patients.