A US Food and Drug Administration advisory committee meeting has recommended restricting the use of PD-1 inhibitors, in a ...

The panel agreed with the FDA that the treatment in which a patient's tissue is processed doesn't fall under the same ...

Update on FDA's Applied Therapeutics, Inc. decision to remove advisory panel for govorestat review in treating galactosemia.

Without sufficient data to work with, FDA advisors were strongly inclined against giving full approval of obeticholic acid ...

The Oncologic Drugs Advisory Committee (ODAC) decided 10-2 with one abstention that PD-1 inhibitors do not have a favorable ...

New data show Talvey’s potential in multiple myeloma drug combinations. Elsewhere, AbbVie got more positive Parkinson’s drug ...

An on-demand video of “Everyone’s Targeting Seafood – CBP Forced Labor, Proposition 65, PFAS, and FDA” is available free for ...

The agency is considering whether to limit the indications of Keytruda, Opdivo, and Tevimbra to PD-L1-positive patients amid testing uncertainties.

Expands available market to include over 200 children’s hospitals in the United StatesLEXINGTON, Mass., Sept. 16, 2024 (GLOBE ...

Merck says FDA advisory panel voted that risk-benefit assessments are not favorable for the use of PD-1 inhibitors and anti-PD-1 antibodies to treat certain cancer patients. FDA’s Oncologic Drugs ...