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 ...
Scientific American

Why the FDA rejected a ‘breakthrough’ melanoma drug

The FDA rejected the promising skin cancer drug RP1 twice, leaving many puzzled and worried about what this means for other ...
Houston Public Media

Psychedelic treatments are on the verge of FDA approval. Why Texas is pushing for them

Texas is helping shape the future of psychedelic therapies. Here's how they work and what access could look like.
Texas Public Radio

Psychedelic treatments are on the verge of FDA approval. Why Texas is pushing for them, and how Texans could gain access

Texas is helping shape the future of psychedelic therapies. Here’s how they work and what access could look like.

FDA moves to limit compounding of GLP-1s

The FDA proposed Thursday not adding three active ingredients in weight-loss drugs to its so-called bulks list.
Regulatory Affairs Professionals Society

FDA cites firms for CGMP violations, failure to submit PMA application

The US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated current good ...
Neurology Advisor

FDA Moves to Real-Time Clinical Trial Patient Monitoring, Faster Drug Review

The FDA is testing real-time clinical trial reporting in an effort to speed up the drug review and approval process.
Medscape

In the Race to the First Psychedelic Approval, Who’s Leading?

A new FDA regulatory pathway could accelerate approval of psychedelic therapies for resistant depression and PTSD, and ...
Government Executive

FDA to pilot real-time clinical drug trials through cloud and AI

The first-of-its-kind pilot could lead to speedier regulatory approval of medical drugs and devices and potentially reduce ...
Psychiatry Advisor

DOJ Moves to Reclassify Approved Marijuana Products to Schedule III

The FDA moved approved marijuana products to schedule III to expand therapy access and state medical programs while ...

How Republicans came to embrace psychedelic drugs

The psychedelic industry is ballooning as new clinical trials spark increased drug development in a race to bring drugs to ...

i-GENTIC AI Expands GENIE to Enforce Full FDA Compliance Lifecycle for Life Sciences

GENIE is the first real-time, LLM-agnostic intelligence engine that converts complex regulations into machine-executable logic for compliance enforcement. i-GENTIC introduces a level of trust and ...