On December 4, 2025, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company) for adults with relapsed or refractory […]

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this […]

On December 3, 2025, the Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with relapsed or refractory chronic […]

Reference: 21 CFR 361.1(c)(1) A Radioactive Drug Research Committee (RDRC) must consist of at least five individuals  A physician recognized as a specialist in nuclear medicine [§ […]

Reference: 21 CFR 361.1(d)(1)-(d)(9) The RDRC is responsible for determining whether or not the proposed research study constitutes basic research and if so, whether the following […]

FDA continues to warn consumers about bodybuilding products labeled to contain steroid and steroid-like substances. These bodybuilding products often contain selective androgen receptor modulators, commonly called […]

FDA is concerned about the potential health risks associated with products that claim to treat a variety of health issues or conditions. Consumers should avoid products […]

Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Product: Drugs Recipient: Recipient Name Laura Martin Recipient Title CEO Turbare Manufacturing 925 Jeanette DriveConway, […]

Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Product: Drugs Recipient: Recipient Name Hale N. Dimetry Recipient Title President PQ Pharmacy, LLC 15215 […]