is pleased to announce that it completed its pre-submission meeting with the U.S. Food and Drug Administration ("FDA") as scheduled on March 20, 2025. The purpose of the meeting was to discuss ...

Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet ...

Makary earlier this month distanced himself from the recent shake-ups at the FDA, including the cancellation of its vaccines ...

Fox News contributor Dr. Marty Makary was officially confirmed to lead the FDA in Trump's second administration after a vote ...

The Senate voted Tuesday to confirm the heads of two major federal health agencies. Jay Bhattacharya, MD, PhD, will become ...

Despite the uncertainty currently sweeping through the Food and Drug Administration, President Donald Trump’s pick to lead ...

Q4 2024 revenue of $1.5 million in pharma services; full year revenue of $1.9 millionGraftAssure RUO assay launched July ...

The FDA said it had opted instead to convene a behind-closed-doors meeting of scientific and public health experts from the FDA, CDC, and Defense Department to arrive at its position, which is to ...

With plans on the horizon to develop more drugs, the CEO said the company, before pressing forward with this objective, will first move to develop its capital base. “For sure that where we’re ...

The Senate late Tuesday voted 56-44 to confirm Martin Makary to lead the Food and Drug Administration.  Makary, a former Johns Hopkins University surgeon and author, has been widely seen as a more ...

The absence of an Advisory Committee meeting is generally perceived as a positive sign, suggesting that the FDA may not have significant concerns about the drug’s safety or efficacy profile.