The U.S. Food and Drug Administration has lifted its clinical hold on a late-stage trial of Novavax's COVID-influenza and its ...

An extensive review determined that the ingredient, oral phenylephrine, doesn’t actually relieve nasal congestion.

While personally “disappointed” about the election’s outcome, current FDA Commissioner Robert Califf, M.D., has laid out the ...

The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs ...

The McDonald's logo is pictured in front of a store in Dearborn ... coli outbreak in the United States, according to CDC. The ...

PK Study Successfully Demonstrates that Fingerprint Sweat Provides Reliable Sample for Drug DetectionFDA 510(k) Clearance ...

Botanix Pharmaceuticals has secured coverage for its FDA-approved Sofdra™ topical gel with Ascent Health, the second-largest payer in the US, extending access to approximately 65 million commercial ...

Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, including the unique device RefluxStop™ for the treatment of acid reflux, a treatment field ...

FDA food recalls are on the rise for several reasons, from undeclared allergens to pathogens. Here's what's wrong with food safety in the US and how you can protect yourself from buying bad products.

The FDA has begun traceback efforts, suggesting that investigators have identified some possible pathogen sources. However, the FDA has not reported what food it is tracing and has not begun on ...

Implantica submits FDA PMA application Clinical Module 2 for RefluxStopâ„¢ for U.S. market approval ...

It comes more than a year after advisors to the FDA unanimously reached the same conclusion. Based on the data, “we are taking this next step in the process to propose removing oral ...