ORDINAL
Pharma Companies Eye ‘First Sale’ Rule to Lessen Tariff Costs Amid New US Trade Measures
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
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
United States Food and Drug Administration, Approved, Akeso, Nasopharyngeal carcinoma, PDCD1 gene, Inhibitor, Akeso ‘s, Anniko
Dupixent notches seventh disease approval with urticaria nod
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
Trodelvy, Triple Negative Breast Neoplasms, Metastatic to, Keytruda, Overall Survival
AstraZeneca, Daiichi say Enhertu delivers ‘highly statistically significant’ efficacy in first-line breast cancer
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
orforglipron, Glucagon-Like Peptide 1, Weight Loss, Oral cavity, orforglipron, Phase 3 Clinical Trials, Diabetes Mellitus, Non-Insulin-Dependent, Hemoglobin A1c measurement, Safety, Injectables
FDA clears its first prescription migraine app, from Click Therapeutics
United States Food and Drug Administration, CT-132, Migraine Disorders, Click Therapeutics, click, first
: BMS’ Opdivo plus Yervoy snags FDA nod as first-line treatment for certain colorectal cancer patients
United States Food and Drug Administration, Approved, Burning Mouth Syndrome, Colorectal Carcinoma, Yervoy, first-line, Combined
Novo inks second obesity deal of the week, with Lexicon oral drug partnership worth up to $1B
Obesity, LX9851, lexicon, Mechanism (attribute)