Healio

FDA clears investigational new drug application for ER-100

Life Biosciences plans to begin human clinical trials of a cellular rejuvenation therapy in optic neuropathies after ...
CURE

FDA Accepts Ivonescimab Application for EGFR Lung Cancer

The FDA accepted an application for ivonescimab with chemotherapy for patients with lung cancer driven by EGFR changes after ...

Legal questions swirl around FDA’s new expedited drug program, including who should sign off

A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been ...

Corcept shares tumble after FDA letter reveals warnings before drug rejection

By Kamal Choudhury Jan 30 (Reuters) - Shares of Corcept Therapeutics fell 16% on Friday after a corrected "complete response ...
JD Supra

OIG Deems Free Drug Patient Assistance Program Low-Risk in Advisory Opinion 25-01

On January 15, 2025, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 25-01, a favorable opinion analyzing a pharmaceutical manufacturer’s ...

Takeaways from the AP’s report on turmoil surrounding the FDA’s new fast-track drug program

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on drugs cleared under a new plan to slash FDA drug review times.
Healio

FDA clears investigational new drug application for NOV05

The FDA cleared an investigational new drug application to advance NOV05 in a phase 2 clinical trial in noninfectious ...