US FDA places clinical hold on Regenxbio's rare disease program

Jan 28 (Reuters) - Regenxbio said on Wednesday the U.S. Food and Drug Administration has placed a clinical hold on two of its ...

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 ...
BioSpace

CDMOs Pin Hopes for Accelerating Uptake at New US Sites on FDA’s PreCheck Program

The initiative could tackle the first-mover disadvantage some CDMOs believe deters early customers, but leaders at companies ...

Some drugmakers quietly concerned about legal risk with speedy FDA review program

More than half a dozen major drugmakers are participating in the Trump administration's speedier review program for new ...

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.
JD Supra

FDA Expands Early Alert Program to All Medical Devices

On September 29, 2025, the U.S. Food and Drug Administration (FDA) announced the expansion of its Early Alert program to include all medical devices. This expansion builds on a pilot program that ...
BioSpace

FDA Lifts One of Two Clinical Holds on Intellia’s ATTR Gene Editing Program

After a patient safety signal and then death, the FDA in October 2025 placed holds on two of the company’s CRISPR programs ...
BioWorld

FDA says TAP program a big hit to date, but key indicators await

The U.S. FDA’s device center posted a report on the TAP program, stating that the metrics available to date suggest the ...

Exclusive-US FDA delays two drug reviews in new voucher program after safety, efficacy concerns

By Patrick Wingrove Jan 15 (Reuters) - The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track program after agency scientists ...
JD Supra

New FDA Program Prioritizes Review of Certain ANDAs

On October 3, 2025, the U.S. Food and Drug Administration (FDA) unveiled a pilot prioritization program that provides for accelerated review of abbreviated new drug applications (ANDAs) for generic ...
Becker's Hospital Review

FDA delays 2 drug reviews in priority voucher program

FDA delays drug reviews for two priority voucher drugs amid safety and efficacy concerns, extending timelines for Sanofi and Disc Medicine products.
MobiHealthNews

FDA opens applications for digital health pre-certification pilot program

The FDA is moving forward surprisingly quickly with its plan to create a pre-certification program for digital health app developers, originally announced in a blog post by new FDA Commissioner Dr.