Japan has suffered from what is known as the “drug loss” phenomenon. Its highly conservative regulatory stance, including a requirement that drugs be tested on Japanese subjects in addition to ...

Supernus Pharmaceuticals' FDA approval for ONAPGO in Parkinson's Disease offers optimism despite past challenges, with a ...

Understanding the reasoning and process of Medicare Advantage prior authorization can help you gain faster approval for a required prior authorization.

Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...

The fallout from the F.D.A.’s rejection of MDMA-assisted treatment for PTSD worries researchers and experts who fear other ...

APAC offers stability in an increasing challenging global geopolitical environment for clinical stage drug development.

Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...

Less than two months after an accelerated approval from the FDA, a drug combination featuring Pfizer’s Braftovi has turned in ...

Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...

You may have heard in the news that the U.S. Food and Drug Administration will no longer allow the use of FD&C Red Dye No. 3 ...

The Food and Drug Administration approved the pill from Vertex Pharmaceuticals for acute pain that often occurs after surgery ...

The cannabis industry and its financial partners see potential gains under Trump, either in the form of direct changes in ...