Approved – Page 2

FDA Approves Cytokinetics’ Myqorzo for Obstructive Hypertrophic Cardiomyopathy, Positioning It Against BMS’s Camzyos

1 month ago talkbio0Tagged Aficamten, Approved, Camzyos, Cytokinetics, Hypertrophic obstructive cardiomyopathy, Myers Squibb, Myqorzo, United States Food and Drug Administration

FDA approval; Cytokinetics; Myqorzo; aficamten; obstructive hypertrophic cardiomyopathy; Bristol Myers Squibb; Camzyos

Bayer’s Finerenone Approved in Japan for Chronic Heart Failure Treatment

1 month ago talkbio0Tagged Approved, Bayer, Chronic heart failure, FINEARTS-HF, finerenone, HFmrEF, HFpEF, Japan, Kerendia

Finerenone; Kerendia; Japan approval; chronic heart failure; HFmrEF; HFpEF; Bayer; FINEARTS-HF

Lilly seeks rapid FDA approval for oral GLP-1 orforglipron after positive obesity “switching” study

1 month ago talkbio0Tagged Approved, Clinical Trials, Eli, Glucagon-Like Peptide 1, injectable incretins, national priority review voucher, Obesity, Oral cavity, orforglipron, Phase 3 trial, United States Food and Drug Administration, Wegovy, weight maintenance, Zepbound

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 month 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

1 month 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

1 month 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

1 month 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

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

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

Dyne Therapeutics Reports Positive Results for Duchenne Drug DYNE-251, Plans FDA Approval Submission

1 month ago talkbio0Tagged Accelerated, Approved, Biological Factors, Breakthrough Therapy Designation, Clinical Trials, DELIVER (veterinary product), Dyne Therapeutics, DYNE-251, License Application, Muscular Dystrophy, Duchenne, United States Food and Drug Administration

Dyne Therapeutics; DYNE-251; Duchenne muscular dystrophy; exon 51 skipping; DELIVER trial; FDA Breakthrough Therapy Designation; Biologics License Application; accelerated approval

Keytruda Breaks New Ground with FDA Approval for Perioperative Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma

2 months ago talkbio0Tagged Adjuvant Therapy, Approved, Clinical Trials, Event-Free Survival, Gene Expression, KEYNOTE-689 trial, Keytruda, Neoadjuvant Therapy, PD-L1, pembrolizumab, perioperative, Squamous cell carcinoma of the head and neck, United States Food and Drug Administration

Keytruda; pembrolizumab; perioperative treatment; head and neck squamous cell carcinoma; HNSCC; FDA approval; KEYNOTE-689 trial; neoadjuvant therapy; adjuvant therapy; PD-L1 expression; event-free survival; clinical trial