2025 Biological License Application Approvals

by Pill Pals Customer Service | Jun 12, 2025 | News

This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. The applications are listed by date of approval.2025 Biological License Application ApprovalsTradename/Proper...

Submit an eCTD or Standardized Data Sample

by Pill Pals Customer Service | Jun 12, 2025 | News

CDER would like to assist sponsors and applicants who have not previously submitted standardized study data and who are planning a submission to CDER. We offer a process to validate sample standardized study datasets. You must have an NDA, IND, BLA, ANDA, or DMF...

Peromyscus spp. Deer Mice as Rodent Model of Acute Leptospirosis

by Pill Pals Customer Service | Jun 12, 2025 | News

Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: National Animal Disease Center, US Department of Agriculture Agricultural...

FDA approves mitomycin intravesical solution for recurrent low-grade

by Pill Pals Customer Service | Jun 12, 2025 | News

On June 12, 2025, the Food and Drug Administration approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).Full prescribing information for Zusduri...

Medtronic Announces Voluntary Recall of Select Newport™ HT70 and Newport™ HT70 Plus Ventilators and Certain Related Newport™ Service Parts

by Pill Pals Customer Service | Jun 11, 2025 | News

Summary Company Announcement Date: June 11, 2025 FDA Publish Date: June 11, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Device & Drug Safety – Potential Defect Company Name: Medtronic Brand Name: Product...

Correction: Vol. 30, No. 6

by Pill Pals Customer Service | Jun 11, 2025 | News

Correction: Vol. 30, No. 6 Volume 31, Number 7—July 2025 Altmetrics Click a source for Altmetric details What is the Altmetric Attention Score? The Altmetric Attention Score for a research output provides an indicator of the amount of attention that it has received....