Approved – Talk Bio

Eli Lilly; orforglipron; oral GLP-1; FDA approval; national priority review voucher; ATTAIN-MAINTAIN trial; obesity treatment; weight maintenance; Zepbound; Wegovy; injectable incretins; Phase 3 trial

GSK wins FDA approval for ultra-long-acting asthma drug Exdensur (depemokimab)

1 week ago talkbio0Tagged Approved, Asthma, biology (field), Depemokimab, dosing, eosinophilic, Exdensur, IL-5 Inhibitor, Phenotype, Severe (severity modifier), SmithKline Beecham, twice-yearly, type 2 inflammation, ultra-long acting, United States Food and Drug Administration

GSK; Exdensur; depemokimab; FDA approval; severe asthma; ultra-long-acting biologic; twice-yearly dosing; type 2 inflammation; eosinophilic phenotype; IL-5 inhibitor

FDA Approves Enhertu-Perjeta Combo for First-Line Treatment of HER2+ Metastatic Breast Cancer

2 weeks ago talkbio0Tagged Approved, Carcinoma breast stage IV, Enhertu, first-line, HER2-positive, Perjeta, United States Food and Drug Administration

Enhertu; Perjeta; FDA approval; HER2-positive; metastatic breast cancer; first-line

FDA approves new gonorrhea antibiotics from GSK and Innoviva

2 weeks ago talkbio0Tagged Antibiotic Resistance, Microbial, Approved, Blujepa, first-in-class antibiotic, gepotidacin, Gonorrhea, Gonorrhea genitourinary NOS, Innoviva, Nuzolvence, Oral treatment, SmithKline Beecham, Uncomplicated, United States Food and Drug Administration, zoliflodacin

gonorrhea; antibiotic resistance; GSK; Blujepa; gepotidacin; Innoviva; Nuzolvence; zoliflodacin; FDA approval; uncomplicated urogenital gonorrhea; first-in-class antibiotic; oral treatment

FDA broadens label for Amgen’s Uplizna as it enters rare disease competition

2 weeks ago talkbio0Tagged AChR-positive, amgen, Approved, disease market, dosing, expansion, gMG, IgG4-Related Disease, inebilizumab, Infrequent, Labels (device), MINT trial, MuSK-positive, Myasthenia Gravis, Generalized, Neuromyelitis Optica, twice-yearly, United States Food and Drug Administration, Uplizna

Uplizna; inebilizumab; Amgen; FDA approval; label expansion; generalized myasthenia gravis; gMG; AChR-positive; MuSK-positive; neuromyelitis optica spectrum disorder; NMOSD; IgG4-related disease; rare disease market; MINT trial; twice-yearly dosing

FDA Approves GSK’s Gepotidacin (Blujepa) for Uncomplicated Urogenital Gonorrhea

2 weeks ago talkbio0Tagged Antibiotics, Approved, Blujepa, gepotidacin, Gonorrhea, SmithKline Beecham, United States Food and Drug Administration

GSK; gepotidacin; Blujepa; FDA approval; gonorrhea; antibiotic