by Pill Pals Customer Service | Jun 3, 2025 | News
On This Page Date: January 22, 2025 Time: 1:00 p.m. – 3:00 p.m. ET Topic & PresentationsSpeakersBsUFA III Regulatory Science Pilot Program: Progress Update BsUFA Program Introduction & Recap from Last EngagementDarlese Solorzano, MS, MBASenior Program...
by Pill Pals Customer Service | Jun 3, 2025 | News
This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without...
by Pill Pals Customer Service | Jun 3, 2025 | News
On June 3, 2025, the Food and Drug Administration (FDA) approved darolutamide (Nubeqa, Bayer Healthcare Pharmaceuticals Inc.) for metastatic castration-sensitive prostate cancer (mCSPC). The FDA previously approved darolutamide in combination with docetaxel for...
by Pill Pals Customer Service | Jun 3, 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. Natalie N. Tarbuck1, Sofya K. Garushyants1, Dillon S. McBride, Patricia M. Dennis, John...
by Pill Pals Customer Service | Jun 3, 2025 | News
Recipient: Recipient Name Amy Lightner, MD Amy Lightner MD 604 Beardsley LaneAudtin, TX 78746United States amylightner8@gmail.com Issuing Office: Center for Biologics Evaluation and Research (CBER) United States Secondary Issuing Offices Dear Dr. Lightner:The Food and...
by Pill Pals Customer Service | Jun 2, 2025 | News
Patient input is a critical part of CBER’s understanding of diseases and conditions. Engaging with patients and caregivers, and listening to their perspectives on their diseases and treatments, may help us advance patient-focused medical product development. CBER’s...
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