XORTX Therapeutics (XRTX) provided an update regarding communications with the US Food and Drug Administration. At the request of the FDA a ...

is pleased to announce that it completed its pre-submission meeting with the U.S. Food and Drug Administration ("FDA") as scheduled on March 20, 2025. The purpose of the meeting was to discuss ...

The purpose of the FDA meeting was to discuss the FDA’s expectations with respect to the requirements necessary for the granting of traditional approval of Olvi-Vec. In response to a question ...

The purpose of this meeting will be to review the XRx-026 program and its readiness for submission of a New Drug Application ...

It's not yet been a week since Marty Makary, M.D., was confirmed to lead the FDA as its commissioner. | Peter Marks, M.D., Ph ...

Days after the U.S. FDA cancelled an annual meeting to discuss the makeup of the following season's flu vaccine, FDA Commissioner nominee Marty Makary pledged to review that decision if he is ...

The purpose of the meeting was to reach agreement with the FDA on the proposed content and format of the Company's planned sNDA submission including the clinical and nonclinical requirements. Based on ...

The Senate voted Tuesday to confirm the heads of two major federal health agencies. Jay Bhattacharya, MD, PhD, will become ...

"So if you are confirmed, will you commit to immediately reschedule that FDA Vaccine Advisory Committee meeting to get the expert views?" Sen. Patty Murray, D-Wash., asked Trump's FDA pick.

We are very happy to have been granted a meeting with the FDA to review the positive OnTarget results in breast cancer patients and our goal is to discuss the most efficient pathways to make ...