Janssen Vaccines Corp., A Johnson & Johnson Company – 713194
Delivery Method: VIA EMAIL WITH READ RECEIPT Product: Drugs Recipient: Recipient Name Mr. John Yi Recipient Title General Manager Janssen Vaccines Corp., A Johnson & Johnson Company 23, Harmony-ro 303beon-gilYeonsu-guIncheon22014South Korea Issuing Office: Center...Cellebration LLC – 713252 – 09/12/2025
Delivery Method: VIA UPS and Electronic Mail Reference #: CBER 25-713252 Product: Biologics Recipient: Recipient Name George Kaltner Recipient Title Chief Executive Officer and President Cellebration LLC (b)(6)San Juan 00909Puerto Rico george@cellebration.com Issuing...Ralph A. DeFronzo, M.D./University of Texas Health Science Center at San Antonio – 716773
Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-09-02 Product: Drugs Recipient: Recipient Name Ralph A. DeFronzo, M.D. Recipient Title Department of Medicine, Diabetes Division Ralph A. DeFronzo, M.D./University of Texas Health Science...Invasive Urogenital Neisseria meningitidis Serogroup Y Multilocus Sequence Type 1466
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. To the Editor: Coincident outbreaks of Neisseria meningitidis serogroup Y (MenY) multilocus...FDA use of Real-World Evidence in Regulatory Decision Making
CLOZARIL (clozapine) NDA 019758Heritage Life Sciences (Barbados) c/o Heritage Life Sciences Therapeutics (USA)Veterans Health Administration (VHA) medical and pharmacy records Descriptive studyIn FDA’s review of the effectiveness of the clozapine REMS, FDA conducted...Organ Donor Transmission of Rickettsia typhi to Kidney Transplant Recipients, Texas, USA, 2024
Murine or fleaborne typhus, an infection caused by the endotheliotropic bacterium Rickettsia typhi, occurs throughout temperate and tropical regions of the world. Murine typhus typically manifests as an undifferentiated febrile illness with severe headache, myalgia,...FDA Responds to Evidence of Possible Association Between Autism and Acetaminophen Use During Pregnancy
For Immediate Release: September 22, 2025 The U.S. Food and Drug Administration today initiated the process for a label change for acetaminophen (Tylenol and similar products) to reflect evidence suggesting that the use of acetaminophen by pregnant women may be...Investigation of Possible Intraoperative Transmission of Brucella melitensis, Slovenia
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: University Medical Centre Ljubljana, Ljubljana, Slovenia (I. Potparić, K....Click To Verify Security & Validation
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