News Related to FDA

FDA Approves NARCAN Nasal Spray Multipacks for High-Volume Distribution

Feb 13, 2026

Emergent BioSolutions received FDA approval on Feb. 12, 2026, for 6-count and 24-count multipack configurations of over-the-counter NARCAN Nasal Spray, designed to meet the needs of partners distributing higher volumes of naloxone to community programs.

FDA Removes Black Box Warning from Menopausal Hormone Therapy Products

Feb 13, 2026

The FDA has approved labeling changes to six menopausal hormone therapy products, removing boxed warnings related to cardiovascular disease, breast cancer, and probable dementia that had been in place since 2003.

FDA Shifts to Single Pivotal Trial Default and Updates Clinical Trial Participation Standards

Feb 13, 2026

The FDA announced a new policy making one robust pivotal trial plus confirmatory evidence the default approval requirement, ending the two-trial standard. Separately, the agency finalized guidance on enhancing clinical trial participation to improve enrollment diversity.

Existing Drug May Overcome Immunotherapy Resistance in Rare Liver Cancer

Feb 13, 2026

Study finds FDA-approved drug AMD3100 can mobilize immune T cells to attack fibrolamellar carcinoma, a rare liver cancer affecting children and young adults that has resisted immunotherapy treatment.

AI and New Drug Targets Advance Alzheimer's Research Pipeline

Feb 13, 2026

Artificial intelligence is increasingly used to analyze Alzheimer's datasets and inform drug discovery, while researchers identify promising new drug targets including the IDOL enzyme and somatostatin receptors that could lead to more affordable treatments.

Lyell Immunopharma Doses First Patient in Phase 3 Head-to-Head CAR T-Cell Trial for Lymphoma

Feb 12, 2026

Lyell Immunopharma has initiated dosing in its Phase III PiNACLE – H2H trial, comparing ronde-cel against approved CAR T-cell therapies for relapsed or refractory large B-cell lymphoma in second-line treatment.