ORDINAL – Talk Bio

FDA Rejects Roche’s Columvi for Earlier-Line Diffuse Large B-Cell Lymphoma

3 days ago talkbio0Tagged Accelerated, Approved, Columvi, Complete, Diffuse Large B-Cell Lymphoma, gemcitabine, genentech, oxaliplatin, Rejection, Response Letter, Roche (company), second, second-line treatment, STARGLO, Third line treatment, United States Food and Drug Administration

FDA rejection; Columvi; Roche; Genentech; diffuse large B-cell lymphoma; DLBCL; STARGLO study; second-line treatment; Complete Response Letter; gemcitabine; oxaliplatin; accelerated approval; third-line therapy

Pharma Companies Eye ‘First Sale’ Rule to Lessen Tariff Costs Amid New US Trade Measures

2 months ago talkbio0Tagged customs loophole, drug import duties, Drug Industry, first, minimis exemption, sale rule, tariff avoidance, trade compliance, Trump administration, U.S., US tariffs

first sale rule; pharmaceutical industry; US tariffs; customs loophole; drug import duties; tariff avoidance; trade compliance; Trump administration; de minimis exemption

Capricor shares turn red as FDA plans deramiocel adcomm, likely the first under new commissioner

3 months ago talkbio0Tagged Biologics License Application, Capricor, deramiocel, first, Market, Review [Publication Type], United States Food and Drug Administration

United States Food and Drug Administration, Capricor, deramiocel, Market, Review [Publication Type], Biologics License Application, first

Akeso’s PD-1 inhibitor notches inaugural FDA nod for nasopharyngeal cancer

3 months ago talkbio0Tagged Akeso, Akeso 's, Anniko, Approved, Inhibitor, Nasopharyngeal carcinoma, PDCD1 gene, United States Food and Drug Administration

United States Food and Drug Administration, Approved, Akeso, Nasopharyngeal carcinoma, PDCD1 gene, Inhibitor, Akeso ‘s, Anniko

Dupixent notches seventh disease approval with urticaria nod

3 months ago talkbio0Tagged Approved, Chronic Spontaneous Urticaria, Dupixent, seventh, United States Food and Drug Administration, Urticaria

Dupixent, Chronic Spontaneous Urticaria, Approved, Urticaria, United States Food and Drug Administration, seventh

Gilead eyes earlier use of Trodelvy in TNBC as Phase III hits key goal

3 months ago talkbio0Tagged Keytruda, Metastatic to, Overall Survival, Triple Negative Breast Neoplasms, Trodelvy

Trodelvy, Triple Negative Breast Neoplasms, Metastatic to, Keytruda, Overall Survival

AstraZeneca, Daiichi say Enhertu delivers ‘highly statistically significant’ efficacy in first-line breast cancer

3 months ago talkbio0Tagged Antibodies, Antibody-Drug Conjugates, AstraZeneca, Daiichi, deruxtecan-nxki, Enhertu, fam-trastuzumab, first-line therapy, HER2-positive metastatic breast cancer, pertuzumab, Progression-Free Survival, Sankyo

Enhertu, fam-trastuzumab deruxtecan-nxki, AstraZeneca, Daiichi Sankyo, HER2-positive metastatic breast cancer, first-line therapy, progression-free survival, antibody drug conjugate (ADC), pertuzumab

Lilly’s oral GLP-1 succeeds in first Phase III test, delivering promising weight loss

3 months ago talkbio0Tagged Diabetes Mellitus, Non-Insulin-Dependent, Glucagon-Like Peptide 1, Hemoglobin A1c measurement, Injectables, Oral cavity, orforglipron, Phase 3 Clinical Trials, Safety, Weight Loss

orforglipron, Glucagon-Like Peptide 1, Weight Loss, Oral cavity, orforglipron, Phase 3 Clinical Trials, Diabetes Mellitus, Non-Insulin-Dependent, Hemoglobin A1c measurement, Safety, Injectables