Gilead Sciences has announced the European Medicines Agency’s (EMA) validation for a parallel accelerated review of ...

A groundbreaking injectable designed to curb the global spread of HIV is now at risk of being delayed due to Donald Trump's ...

US antivirals giant Gilead Sciences recently announced that the US Food and Drug Administration (FDA) has accepted its New ...

The US Food and Drug Administration (FDA) has accepted Gilead’s new drug application (NDA) for lenacapavir and set a ...

Gilead Sciences has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application ...

Gilead (GILD) announced that the European Medicines Agency has validated for parallel accelerated review the company’s marketing authorization ...

Analysts at RBC Capital Markets have predicted twice-yearly lenacapavir could become a $2 billion product, and become a key ...

It was a busy week for the biotech sector. While the fourth-quarter earnings season is nearing the end, other pipeline and regulatory updates were in focus. Recap of the Week’s ...

Foster City, California Tuesday, February 25, 2025, 16:00 Hrs [IST] ...

Lenacapavir is a twice-yearly injectable medication designed to be used as pre-exposure prophylaxis (PrEP). The FDA is giving ...

Twice-yearly lenacapavir PrEP could be available as early as this summer pending federal Food and Drug Administration ...

The EMA validation follows the announcement last week that the U.S. Food and Drug and Administration (FDA) accepted Gilead’s New Drug Applications (NDAs) for lenacapavir for PrEP and will assess ...