FDA
Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Magenta Therapeutics, Inc. (Nasdaq: MGTA) today announced that it has received a clinical hold letter from the U.S. Food and Drug Administration (FDA) related to its Investigational New Drug Application (IND) filed in June 2021 to initiate a Phase 1/2 clinical trial of MGTA-117 in patients with acute…
Read More
Excerpt from the Press Release: WATERTOWN, Mass.–(BUSINESS WIRE)–Lyndra Therapeutics, a clinical-stage biotechnology company working to make daily pills a thing of the past, today announced the positive outcome of an end-of-phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) providing a clear path to approval for Lyndra’s Weekly Risperidone (LYN-005), the company’s…
Read More
The FDA has released a new Action Plan on Artificial Intelligence/Machine Learning (AI/ML)- Software as a Medical Device (SaMD). You can download it below by clicking the button! Download The Action Plan
Read More
In March of 2019 the FDA released this statement regarding the value of Expanded Access Programs and the FDA’s encouragement of Sponsors to consider providing them as options for Patient Populations. A few interesting statements worth highlighting in the statement: “Since 2010, drug sponsors and manufacturers have given the opportunity of such access to more…
Read More- « Previous
- 1
- …
- 20
- 21
- 22