The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...

Pharmaceutical consultants apply their comprehensive expertise in different areas to accelerate the drug development process.

With the right policies, advanced science, and strong leadership in government agencies, Donald Trump has the power to save ...

US Health and Human Services secretary Robert F. Kennedy Jr. directs the Food and Drug Administration to explore revamping ...

A new federal commission will ‘investigate’ decades-old mental health as well as weight loss drugs, prompting concerns from ...

Marty Makary, a career surgeon and President Trump’s nominee to run the Food and Drug Administration (FDA), faced senators in ...

New SEC filings from pharmaceutical companies reveal Donald Trump and Elon Musk’s cost-cutting measures could slow drug ...

FDA-approved drugs are also often patented and subject to various laws regarding exclusivity for a given manufacturer. At the ...

The Trump administration’s moves to shrink the federal workforce put the FDA’s ability to regulate drugs and oversee the ...

The FDA accepted a new drug application for SYD-101 to slow the progression of pediatric myopia and assigned a Prescription ...

which are undergoing the US Food and Drug Administration’s (FDA’s) premarket approval (PMA) process, with an additional third-party product it will distribute. The company said the second ...