Multiple Sclerosis

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

Zenas BioPharma Inks $2 Billion+ Licensing Deal With InnoCare for Autoimmune Drug Candidates

2 months ago talkbio0Tagged Autoimmune Diseases, BTK inhibitor, Clinical Trials, Inhibitor, InnoCare, Interleukin-17, Multiple Sclerosis, orelabrtuinib, Pharma, TYK2 gene, Zenas BioPharma

Zenas BioPharma; InnoCare Pharma; autoimmune diseases; multiple sclerosis; BTK inhibitor; orelabrtuinib; licensing deal; clinical trials; IL-17 inhibitor; TYK2 inhibitor

FDA Delays Decision on Sanofi’s Oral Multiple Sclerosis Drug to December 2025

2 months ago talkbio0Tagged BTK inhibitor, Clinical action, December 2025, drug review, Multiple Sclerosis, nrSPMS, PDUFA, sanofi, Tolebrutinib, United States Food and Drug Administration

FDA action date; Sanofi; tolebrutinib; multiple sclerosis; BTK inhibitor; nrSPMS; drug review delay; December 2025; PDUFA

Sanofi’s MS Drug Tolebrutinib Faces FDA Delay Amid Extended Review

2 months ago talkbio0Tagged Breakthrough Therapy, Bruton 's tyrosine kinase inhibitor, Deferred, GEMINI trial, HERCULES trial, Multiple Sclerosis, NDA, nrSPMS, PERSEUS trial, regulatory review, sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; FDA delay; multiple sclerosis; nrSPMS; Bruton’s tyrosine kinase inhibitor; breakthrough therapy; HERCULES trial; GEMINI trial; PERSEUS trial; NDA; regulatory review

Immunic’s MS drug shows ‘modest’ brain volume impact, stock tumbles

7 months ago talkbio0Tagged brain volume, calcium, Disability, Multiple Sclerosis, Progressive, vidofludimus

Multiple Sclerosis, brain volume, Progressive, vidofludimus, calcium, Disability

FDA Issues Boxed Warning for Anaphylaxis Risk with Multiple Sclerosis Drugs Copaxone and Glatopa

10 months ago talkbio0Tagged anaphylaxis, boxed, Cautionary Warning, Copaxone, glatiramer, Glatopa, Multiple Sclerosis, sandoz, Teva, United States Food and Drug Administration

FDA, boxed warning, anaphylaxis, multiple sclerosis, Copaxone, Glatopa, glatiramer acetate, Teva, Sandoz

FDA Adds Boxed Warning to Teva’s Copaxone and Generic Glatopa Due to Anaphylaxis Risk

10 months ago talkbio0Tagged acetate, anaphylaxis, boxed, Cautionary Warning, Copaxone, glatiramer, Glatopa, Hypersensitivity, Multiple Sclerosis, Risk, United States Food and Drug Administration

FDA Boxed Warning, Anaphylaxis Risk, Copaxone, Glatopa, Glatiramer Acetate, Multiple Sclerosis (MS) Treatment, Allergic Reaction

Biogen Raises Profit Guidance Amid Leqembi Growth and MS Sales Decline

1 year ago talkbio0Tagged Biogen, Drug Industry, earnings, Leqembi, Multiple Sclerosis, profit, Report (document)

Biogen, profit guidance, Leqembi, multiple sclerosis, earnings report, pharmaceutical industry

Sanofi’s Frexalimab Shows Promise in Multiple Sclerosis with Positive Phase 2 Results

1 year ago talkbio0Tagged Antibodies, CD40 Ligand, Frexalimab, Multiple Sclerosis, Phase 2 trial, sanofi

Sanofi, Frexalimab, Multiple Sclerosis, Phase 2 Trial, CD40L Antibody

Transforming Multiple Sclerosis Treatment: Emerging Trends and Future Directions

1 year ago talkbio0Tagged Artificial Intelligence, disease-modifying therapies, DNA Integration, Hemopoietic stem cell transplant, High-Efficacy, Multiple Sclerosis, myelin repair, neurorestorative, Precision Medicine

Multiple sclerosis, high-efficacy treatments, stem cell transplantation, disease-modifying therapies, personalized medicine, AI integration, myelin repair, neurorestorative therapies.