This Week at the FDA: Grants and Digital Health

Happy Friday, everyone!

We’re trying something new this week. Instead of wrapping up with an Editor’s Choice article, we’re highlighting four FDA announcements we think you should know.

Check them out!

OBI Pharma Granted FDA Orphan Drug Designation for OBI-3424 for the Treatment of Acute Lymphoblastic Leukemia (ALL)

OBI Pharma sent out some big news this week! Their cancer therapeutic OBI-3424 (which is also being investigated for HCC) has recently received the Orphan Drug Designation from the FDA.

Protagonist Therapeutics Announces Fast Track Designation Granted by U.S. FDA to Hepcidin Mimetic PTG-300

Patients with the Beta Thalassemia may face chronic anemia, but Protagonist Therapeutics is working to change that. This week, the FDA granted them the Fast Track Designation to speed up the process.

FDA Awards 12 Grants to Fund New Clinical Trials to Advance the Development of Medical Products for the Treatment of Rare Diseases

Orphan Products Clinical Trials Grants Program came through with 12 grants for neglected diseases this week. Check out the full list on the FDA’s website.

FDA Budget Matters: Advancing Innovation in Digital Health

FDA Commissioner Scott Gottlieb shared an update on how the FDA is leveraging medical tools for the advancement of patient health.

 


 

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