Concern is growing among public health experts that anti-vaccine sentiments within federal and state governments may derail ...

Appointed John H. Johnson as Executive Chairman; Todd F. Baumgartner, MD, MPH as Chief Regulatory Officer; and Reena Thomas Colacot as Vice ...

LONDON (Reuters) -Trump administration cuts across federal health agencies have sent shivers through a biotech industry ...

After years of back-and-forth with the FDA over Hetlioz's potential use as a jet lag disorder treatment, Vanda ...

The Food and Drug Administration (FDA) announced Thursday it plans to phase out animal testing requirements for biological ...

The EMA's drug approval process is a two-step process, consisting of both the CHMP and EC's decisions. In comparison, the FDA is the only body that conducts regulatory review in the United States ...

U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low ...

The company has also filed for FDA approval of its flu+Covid combination ... the same fate as Novavax’s Covid-19 vaccine: delayed regulatory action. MRNA technology is already used in Moderna ...

While FDA drug and device reviewers and inspectors were protected from layoffs, drug reviews are likely to be affected, ...

Employer health plans brace for ongoing soaring costs as weight-loss drug utilization rises. What trends are coming down the ...

urged the committee to decrease the rules for getting vaping products approved. "There are 18 million adult vapers who are using e-cigarettes to quit smoking, but thanks to the FDA regulatory ...

and the drugmaker has now filed for FDA approval of a second candidate. The latest to reach the regulatory stage is teclistamab, one of two bispecifics for multiple myeloma in the late-stage ...