The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...
A new FDA regulatory pathway could accelerate approval of psychedelic therapies for resistant depression and PTSD, and ...
NPR's Leila Fadel asks Mitch Zeller, former director of the FDA's Center for Tobacco Products, about the agency's approval of fruit-flavored electronic cigarettes.
Market opportunities include gaining a comprehensive understanding of FDA procedures for US pharmaceutical submissions, critical for navigating the largest global market. This course provides deep ...
In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein products. The ...
The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...
April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...
12d
FDA approval, fundraising, and the reality of building in healthcare according to BioticsAI founder
BioticsAI CEO Robhy Bustami joined Isabelle Johannessen on Build Mode to discuss how the company has navigated a highly ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results