The US FDA has cleared an investigational new drug (IND) application for HG202, by HuidaGene Therapeutics. This drug is the ...

The FDA has its own expertise, but as an executive branch ... As to changes he’d like to see in the biopharma industry, ...

The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...

The drug industry witnessed major policy changes during Joe Biden's four-year term as U.S. President, including the historic ...

The FDA updated GLP-1 drug labels to warn of the risk of patients breathing food into their lungs while under anesthesia for ...

With FDA approval of an investigational device exemption, J&J’s soft tissue robot moves a step closer to challenging ...

The president-elect has said he’ll let Robert F. Kennedy Jr. “go wild” on healthcare, while many expect a leadership change ...

Patient advocates are hoping for change under new director Michelle Tarver, while industry groups hope she will build on ...

Following the clearance of an investigational new drug application from the FDA, a phase 1 trial will examine the novel ...

While A.I. promises breakthroughs, industry leaders warn that transparency and patient safety must remain front and center.

REMS programmes are typically implemented after drug approval when the FDA determines that a medication needs to be closely ...