Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
JD Supra

New FDA approval process promotes development of rare disease gene therapies

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 ...
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 ...
Targeted Oncology

FDA Clears IND for Phase 3 Trial of iSCIB1+ in Advanced Melanoma

The FDA cleared the investigational new drug (IND) application for a global phase 3 registrational trial of iSCIB1+, a DNA ...

Revelation Biosciences Reaches Agreement with FDA on Gemini Approval Pathway for AKI

We are grateful for the collaborative feedback from FDA on the Gemini program, which provides us a clear and expedient path forward for seeking approval of Gemini as a treatment for AKI,” said, James ...
NBC 7 San Diego

Moderna Applies for Full FDA Approval of Its Covid Vaccine

Moderna on Tuesday asked the Food and Drug Administration for full U.S. approval of its Covid-19 vaccine — the second drugmaker in the U.S. to seek a biologics license that will allow it to market the ...