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 ...

As Healthcare AI Changes On The Fly, FDA Reconsiders How To Keep It Safe

The FDA's approval process was designed for medical devices that stay largely the same after launch. Clinical AI does not operate this way; it is built to evolve.
FierceBiotech

FDA launches new priority review voucher program for biopharmas that 'align with national priorities'

The FDA is introducing a new priority voucher program designed to shorten the drug review process from 10 to 12 months down to one or two months, according to the agency. The federal outfit’s ...
The Baltimore Sun

FDA announces sweeping changes to speed up the drug review process

The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10 to 12 months for a review to just ...
JD Supra

FDA’s Rare Disease Evidence Principles Process Provides Guidance for Applications Supported by a Single Pivotal Trial

On September 3, 2025, the US Food and Drug Administration (FDA) announced a new process to support the development of drugs intended to treat rare genetic diseases. The Rare Disease Evidence ...
JD Supra

Court gives new life to the post-CRL administrative hearing process, rules that FDA can deny hearing only when evidence is ‘conclusively deficient’

On August 15, 2025, the U.S. Court of Appeals for the D.C. Circuit limited FDA's ability to deny a hearing on the approvability of a new drug application (NDA) based on a lack of “substantial evidence ...
Healio

FDA grants breakthrough designation to ianalumab for Sjögren’s disease

The FDA has granted breakthrough therapy designation to Novartis’ ianalumab for Sjögren’s disease, according to a press release from the manufacturer.In its statement, Novartis said it plans to submit ...