The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development

EDINA, Minn., December 9, 2025 – Lunds & Byerlys is voluntarily recalling its L&B Monster Cookies as the wrong ingredient label was applied to the packaging. Packages may contain undeclared peanuts, egg, and soy. People who have allergies to peanuts, egg, and soy run the

Fukuzyu Pharmaceutical Co., Ltd. – 1/19/2024. Country: Japan. Record Type: 483

CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.

Meetings, conferences, and workshops sponsored or co-sponsored by Center for Drug Evaluation and Research.

On June 11, 2025, the Food and Drug Administration approved taletrectinib (Ibtrozi, Nuvation Bio Inc.), a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 08/08/2025
Short Title (70 char) Olympia Pharmaceuticals. Orlando, FL. 483 issued 08/08/2025
FEI Number 3009724085
Firm Name Olympia Pharmaceuticals
Record Type 483
State FL
Establishment Type Outsourcing Facili