Approved – Talk Bio

FDA Approves Novartis’ Itvisma: Expanding Gene Therapy to Older Spinal Muscular Atrophy Patients

2 hours ago talkbio0Tagged Adult, Approved, gene therapy, intrathecal formulation, Itvisma, Novartis, older children, Spinal Muscular Atrophy, United States Food and Drug Administration, Zolgensma

Novartis; FDA approval; Itvisma; Zolgensma; Spinal Muscular Atrophy (SMA); Gene Therapy; Older Children; Adults; Intrathecal Formulation

FDA Grants Regeneron Two Eylea HD Approvals in One Day

4 days ago talkbio0Tagged aflibercept, Approved, dosing, Eylea, Hodgkin Disease, Macular retinal edema, monthly, Ophthalmology specialty, Regeneron, Retinal Vein Occlusion, RVO, United States Food and Drug Administration

Regeneron; FDA approval; Eylea HD; macular edema; retinal vein occlusion; monthly dosing; aflibercept; ophthalmology; RVO

FDA Approves New Indication and Monthly Dosing for Regeneron’s Eylea HD

5 days ago talkbio0Tagged aflibercept, Approved, dosing, Eylea, Hodgkin Disease, Macular retinal edema, monthly, Ophthalmology specialty, Pre-filled Syringe, Regeneron, Retinal Diseases, Retinal Vein Occlusion, United States Food and Drug Administration

FDA approval; Eylea HD; Regeneron; macular edema; retinal vein occlusion; monthly dosing; ophthalmology; aflibercept; retinal diseases; pre-filled syringe

Japan Approves Anti-CD19 Monoclonal Antibody UPLIZNA for Suppression of Relapse in Immunoglobulin G4-Related Disease (IgG4-RD)

6 days ago talkbio0Tagged Anti-CD19 Monoclonal Antibody, Approved, IgG4-RD, IgG4-Related Disease, Immunoglobulin IgG4, inebilizumab, Japan, Ministry of Health, MITIGATE trial, Mitsubishi Tanabe Pharma, Relapse, Uplizna, Visual Suppression, Welfare

UPLIZNA; Inebilizumab; Anti-CD19 monoclonal antibody; IgG4-related disease (IgG4-RD); Immunoglobulin G4; Japan approval; Relapse suppression; MITIGATE trial; Mitsubishi Tanabe Pharma; Ministry of Health, Labour and Welfare

Roche Bags EU Nod for SC Formulation of Lunsumio, Re-Igniting Bispecific Battle with Tepkinly

6 days ago talkbio0Tagged Antibodies, Bispecific, Approved, Clinical Research, Conditional, EU, GO29781, Lunsumio, Lymphoma, Follicular, marketing authorisation, Relapsed/Refractory, Roche (company), subcutaneous, Tepkinly

Roche; Lunsumio; subcutaneous; EU approval; conditional marketing authorisation; follicular lymphoma; bispecific antibody; Tepkinly; CD20xCD3; relapsed/refractory; GO29781 study

Arrowhead Secures Maiden FDA Approval for Redemplo in Rare Genetic Metabolic Disorder (FCS)

6 days ago talkbio0Tagged Approved, Arrowhead Pharmaceuticals, commercial, Familial chylomicronemia syndrome, Hereditary Diseases, Infrequent, Interferes with, Plozasiran, Redemplo, RNA, Triglycerides, TRiM platform, United States Food and Drug Administration

Arrowhead Pharmaceuticals; FDA approval; Redemplo; plozasiran; familial chylomicronemia syndrome; rare genetic disorder; RNA interference; TRiM platform; triglyceride reduction; first commercial drug

Sandoz Launches Tyruko (Natalizumab-Sztn), First Tysabri Biosimilar, in US After JCV Assay Delays

1 week ago talkbio0Tagged Approved, Biological Assay, Biosimilars, JC Virus, JCV, Leukoencephalopathy, Progressive Multifocal, Multiple Sclerosis, Polpharma Biologics, Progressive, sandoz, Tyruko, Tysabri, United States Food and Drug Administration

Sandoz; Tyruko; Tysabri biosimilar; natalizumab-sztn; multiple sclerosis (MS); biosimilar launch; JCV assay; progressive multifocal leukoencephalopathy (PML); FDA approval; Polpharma Biologics

Lundbeck Fires First Shot in Bidding War With Alkermes Over Sleep Biotech Avadel

1 week ago talkbio0Tagged Alkermes, Approved, Avadel, bidding war, CVR, LUMRYZ, Lundbeck, Primary Hypersomnia, sleep biotech, United States Food and Drug Administration

Lundbeck; Alkermes; Avadel; bidding war; sleep biotech; Lumryz; idiopathic hypersomnia; FDA approval; deal; CVR

Merck Reports Pivotal PCSK9 Pill Data in Race to Beat AstraZeneca to Market

2 weeks ago talkbio0Tagged Approved, AstraZeneca, Autoimmune hemolytic anemia, Cardiovascular Diseases, CORALreef trial, enlicitide, LDL-C, Merck, oral cholesterol pill, PCSK9 inhibitor, United States Food and Drug Administration

Merck; PCSK9 inhibitor; enlicitide; oral cholesterol pill; AstraZeneca; CORALreef trial; LDL-C reduction; AHA 2025; FDA approval; cardiovascular disease

Pfizer Triumphs Over Novo Nordisk with $10B Bid to Acquire Metsera

2 weeks ago talkbio0Tagged Acquisition, Approved, bidding war, Drug Industry, Glucagon-Like Peptide 1, Metsera, Nordisk, Obesity, Pfizer, shareholder

Pfizer; Novo Nordisk; Metsera; obesity drugs; GLP-1; acquisition; bidding war; shareholder approval; pharmaceutical industry