(Reuters) -Federal regulators have asked Novavax to complete an additional clinical trial on its COVID-19 vaccine after ...

The tech giant’s Damo Academy secured a “breakthrough device” designation from the US regulator for its pancreatic ...

The FDA announced it will be reducing, refining and potentially replacing the animal testing requirement for the approval of ...

The bone graft incorporating rhBMP-2 has received FDA IDE approval for a pivotal clinical trial in spinal fusion ...

The legislation would allow the FDA to approve drugs and devices that have already been approved in other industrialized ...

In the fifth episode of a six-part interview series on immunotherapy, Marc Voigt, CEO and Executive Director of Immutep ...

New drug review processes would be accelerated and completed in 120 days in response to a US plan to raise pharmaceutical tariffs, the Ministry of Health and Welfare said yesterday. Food and Drug ...

Alibaba Group Holding’s research arm, Damo Academy, has secured a key endorsement from the US Food and Drug Administration ... an expedited review and approval process, Alibaba said in a ...

Federal regulators are asking Novavax to complete an additional randomized clinical trial on its Covid-19 vaccine after ...

The move comes amid HHS Secretary Robert F. Kennedy Jr.’s decision to force out the top official responsible for reviewing ...

One of the FDA’s recently departed top officials is weighing in on the wide-ranging staff cuts at the agency and how they could imperil the drug approval process that has served as the global ...