January – March 2025 | Potential Signals of Serious Risks/New Safety I

by Pill Pals Customer Service | Jun 30, 2025 | News

ELEVIDYS (delandistrogene moxeparvovec-rokl) Hepatotoxicity-associated fatalities in non-ambulatory patients with Duchenne muscular dystrophyFDA is evaluating the need for regulatory action.FDA Safety Communication was issued on June 24, 2025:FDA Investigating Deaths...

MNEXSPIKE

by Pill Pals Customer Service | Jun 27, 2025 | News

STN: 125835 Proper Name: COVID-19 Vaccine, mRNATradename: MNEXSPIKEManufacturer: ModernaTX, Inc.Indication:For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).MNEXSPIKE is...

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging

by Pill Pals Customer Service | Jun 27, 2025 | News

Summary Company Announcement Date: June 27, 2025 FDA Publish Date: June 27, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Presence of Penicillin G Potassium Injection Vial Company Name: Sandoz Inc. Brand Name: Product...

FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies

by Pill Pals Customer Service | Jun 27, 2025 | News

For Immediate Release: June 27, 2025 The U.S. Food and Drug Administration announced today that it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor CAR T cell...

TECARTUS

by Pill Pals Customer Service | Jun 27, 2025 | News

STN: BL 125703Proper Name: brexucabtagene autoleucelTradename: TECARTUSManufacturer: Kite Pharmaceuticals, Inc.Indication: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:Adult patients with relapsed or...

Shang Hao Jia, Inc. Issues Allergy Alert on Undeclared Sesame in Danshi Brand Spicy Shredded Tofu

by Pill Pals Customer Service | Jun 27, 2025 | News

Summary Company Announcement Date: June 26, 2025 FDA Publish Date: June 27, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Sesame Company Name: SHANG HAO JIA, INC Brand Name: Product Description: Company...