FDA's new expedited drug program raises legal questions and concerns

The FDA commissioner's effort to shorten the review of drugs favored by the Trump administration is causing alarm across the ...
CURE

FDA Accepts Application for Gedatolisib for Some Patients With Breast Cancer

The U.S. Food and Drug Administration (FDA) has accepted a new drug application for gedatolisib for the treatment of patients ...

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 ...

Avacta Announces U.S. Food and Drug Administration Clearance of the Investigational New Drug (IND) Application for the Second pre|CISION® Medicine, FAP-Exatecan (AVA6103)

The Phase 1 clinical study of FAP-Exd (AVA6103) is anticipated to begin later in Q1 2026LONDON and PHILADELPHIA, (GLOBE NEWSWIRE) ...
Targeted Oncology

FDA Grants Priority Review to Gedatolisib for Advanced Breast Cancer

Gedatolisib's NDA for advanced breast cancer treatment has been accepted by the FDA, with a priority review and a PDUFA date ...