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Alumis’ TYK2 Inhibitor Envudeucitinib Succeeds in Phase 3 Psoriasis Trials, Plans FDA Filing

10 hours ago talkbio0Tagged Alumis, Approved, envudeucitinib, Phase 3 trials, Psoriasis, Psoriasis Area and Severity Index Clinical Classification, TYK2 Inhibitor, United States Food and Drug Administration

Alumis; envudeucitinib; TYK2 inhibitor; psoriasis; Phase 3 trials; FDA approval; PASI 75

ScinoPharm Taiwan Secures Historic U.S. FDA Approval for Glatiramer Acetate Injection to Treat Multiple Sclerosis

3 days ago talkbio0Tagged Approved, Complex, glatiramer acetate, Multiple Sclerosis, ScinoPharm, Taiwan, United States Food and Drug Administration

ScinoPharm; FDA Approval; Glatiramer Acetate; Multiple Sclerosis; Taiwan; Complex Generic

Vanda Pharmaceuticals Secures FDA Approval for NEREUS (Tradipitant), First New Motion Sickness Drug in Over 40 Years

5 days ago talkbio0Tagged Approved, Motion Sickness, NEREUS, Tradipitant, United States Food and Drug Administration, Vanda Pharmaceuticals, vomiting prevention

Vanda Pharmaceuticals; FDA approval; NEREUS; tradipitant; motion sickness; vomiting prevention

Agios Pharmaceuticals Secures FDA Approval for Aqvesme (Mitapivat) in Thalassemia Treatment

5 days ago talkbio0Tagged Agios Pharmaceuticals, Anemia, Approved, Aqvesme, mitapivat, Thalassemia, United States Food and Drug Administration

Agios Pharmaceuticals; FDA approval; thalassemia; Aqvesme; mitapivat; anemia

Novo Nordisk Wins FDA Approval for First Oral GLP-1 Wegovy Pill in Obesity Treatment

2 weeks ago talkbio0Tagged Approved, Glucagon-Like Peptide 1, Novo Nordisk, Obesity, oral semaglutide, United States Food and Drug Administration, Wegovy pill

Novo Nordisk; Wegovy pill; FDA approval; oral semaglutide; obesity treatment; GLP-1

FDA Approves Novo Nordisk’s Wegovy Pill as First Oral GLP-1 for Weight Management

2 weeks ago talkbio0Tagged Approved, Novo Nordisk, Obesity, oral semaglutide, United States Food and Drug Administration, Wegovy pill

Novo Nordisk; Wegovy pill; FDA approval; obesity treatment; oral semaglutide

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

2 weeks 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

2 weeks 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

3 weeks 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)

3 weeks 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