by Pill Pals Customer Service | Jun 27, 2025 | News
STN: BL 125643Proper Name: axicabtagene ciloleucelTrade Name: YESCARTAManufacturer: Kite Pharma Inc.Indication: YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:Product InformationSupporting DocumentsJune...
by Pill Pals Customer Service | Jun 27, 2025 | News
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136) was signed into law. In addition to aiding the COVID-19 response efforts, the CARES Act amended the FD&C Act to include statutory provisions that (1) reform...
by Pill Pals Customer Service | Jun 27, 2025 | News
STN: BLA 125736Proper Name: Idecabtagene VicleucelTradename: ABECMAManufacturer: Celgene Corporation, a Bristol-Myers Squibb CompanyIndications:Treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including...
by Pill Pals Customer Service | Jun 26, 2025 | News
FDA Safety Communication – June 26, 2025The Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies have been eliminated because the Food and Drug Administration...
by Pill Pals Customer Service | Jun 26, 2025 | News
STN:125746 Proper Name: ciltacabtagene autoleucelTradename: CARVYKTIManufacturer: Janssen Biotech, Inc.Indications: Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 1 prior line of therapy, including a proteasome...
by Pill Pals Customer Service | Jun 26, 2025 | News
Docket Number: FDA-2021-D-1158 Issued by: Guidance Issuing Office Center for Devices and Radiological Health Center for Biologics Evaluation and Research This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the...
by Pill Pals Customer Service | Jun 26, 2025 | News
Submit Comments by 09/24/2025 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written...
by Pill Pals Customer Service | Jun 26, 2025 | News
AUDIENCE: Pediatrics, Pharmacy, Family Practice, Internal Medicine, CardiologyISSUE: FDA has required and approved updates to the Prescribing Information for Comirnaty (COVID-19 Vaccine, mRNA) manufactured by Pfizer Inc. and Spikevax (COVID-19 Vaccine, mRNA)...
by Pill Pals Customer Service | Jun 26, 2025 | News
Docket Number: FDA-2013-D-0744 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of New Drugs The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Antibacterial...
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