United States Food and Drug Administration
FDA Greenlights Amgen’s Innovative T Cell Therapy for Aggressive Lung Cancer
FDA, Amgen, T cell engager, lung cancer, aggressive, AMG 757, bi-specific T cell engager, small cell lung cancer, immunotherapy, cancer treatment, clinical trials.
Bristol Myers’ Breyanzi Expands Indications to Include Follicular Lymphoma
Bristol Myers, Breyanzi, CAR-T therapy, follicular lymphoma, FDA approval, cancer treatment, immunotherapy.
Bristol Myers’ Breyanzi Approved by FDA for Follicular Lymphoma, Joining Gilead and Novartis in CAR-T Treatment
Bristol Myers, Breyanzi, FDA, follicular lymphoma, CAR-T, Gilead, Novartis, cancer treatment, immunotherapy
ICER Raises Concerns Over Uncertainties in Lykos MDMA Clinical Trials Ahead of FDA Advisory Committee Meeting
ICER, Lykos, MDMA, clinical trials, uncertainties, FDA, AdComm, advisory committee meeting
Ascendis Hormone Replacement Therapy Faces Setback with FDA Review Extension
Ascendis Pharma, hormone replacement therapy, FDA review, delay, three-month extension.
FDA Rejects Hepatitis B Vaccine Update Due to Inadequate Documentation and Data
FDA, hepatitis B vaccine, vaccine update, document destruction, insufficient data, rejection
Extended FDA Review Timeline for Ascendis’ Hormone Therapy
Ascendis Pharma, hormone therapy, FDA review, delay, 3 months extension.
Eisai and Biogen Overcome Filing Hitch, Initiate FDA Submission for Subcutaneous Leqembi
Eisai, Biogen, FDA submission, Leqembi, subcutaneous, Alzheimer’s disease, rolling submission, BLA, clinical trials, monoclonal antibody, amyloid beta, neurodegenerative disorder
FDA Imposes Three-Month Delay on Ascendis’ Hypoparathyroidism Treatment
Ascendis Pharma, hypoparathyroidism, FDA, drug approval, delay, three-month setback, regulatory hurdle, treatment, endocrine disorder.
FDA Rejects Dynavax’s Heplisav-B Expansion Due to Data Gaps
FDA, Dynavax, Heplisav-B, data gaps, rejection, expansion, vaccine, hepatitis B