Jefferies analysts said the approval was largely expected and an “incremental positive” for Moderna amid questions about the ...

The overturning of the FDA’s lab-developed tests rule is just the tip of the iceberg. With the loss of Chevron deference, ...

In 2018, the FDA began an investigation into nitrosamine impurities in drugs that led to high-profile recalls for heartburn ...

Arguably the most notable of the FDA’s upcoming decisions is that regarding Gilead’s twice-yearly HIV prophylaxis lenacapavir ...

The medium-sized biopharma is showing off new results from dordaviprone and Zepzelca, both of which were acquired through ...

Although the FDA has rejected Stealth’s new drug application for Barth syndrome candidate elamipretide, the agency identified ...

According to the nonprofit news outlet NOTUS, at least seven studies cited in the Make America Healthy Again report released ...

Despite mixed results, analysts maintained faith in ivonescimab’s ability to cross over between Eastern and Western patient ...

Analysts at Truist Securities admitted that the result for itepekimab, which the companies were hoping to follow their ...

The National Legal and Policy Center, a right-wing advocacy and watchdog group, had asked the company to revisit its DEI ...

At the heart of the deal is an anti-Claudin18.2 antibody-drug conjugate being developed for solid tumors, including gastric ...

Keros will be down to 85 full-time employees after the layoffs and expects to generate annualized savings of $17 million.