Ekterly’s road to approval was not a smooth one. Last month, the FDA informed KalVista it would not meet its PDUFA date due ...

Despite rehiring hundreds of FDA, CDC and NIH employees, the Department of Health and Human Services is still a skeleton of ...

TIGIT-targeting therapies have largely disappointed in recent months, with failed studies, terminated partnerships and ...

Slashing adverse drug reactions through pharmacogenetics and advanced AI could help rehabilitate the pharmaceutical ...

Why did two private equity firms with more than $460 billion under management want a little old gene therapy biotech called ...

While it trails Johnson & Johnson’s Tecvayli, Regeneron still hopes Lynozyfic can differentiate in terms of dosing ...

Pfizer insists that the discontinuation of the Phase II study was due to recruitment difficulties and was not linked to ...

The safety update for Vyvgart rattled argenx’s shares on Monday, a reaction that analysts at William Blair said was “overdone ...

The pivotal trial for Neurogene's Rett syndrome gene therapy makes use of baseline controls and a rigorous endpoint that ...

Bioinformatics is on the rise, forecasted to grow by about $16 billion from 2024 to 2029 given its value to managing mass ...

Analysts believe that Gilead's new PrEP drug Yeztugo could reach peak sales of $4.5 billion. Not if GSK has anything to say ...

Cell and gene therapy leaders say the agency’s decision to remove the Risk Evaluation and Mitigation Strategies that had been ...