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Ionis Receives Breakthrough Therapy Designation for Zilganersen for Alexander Disease
Wednesday, December 03, 2025Ionis Pharmaceuticals has announced that the US Food and Drug Administration FDA has granted Breakthrough Therapy designation to zilganersen a potential treatment for Alexander disease AxD
IQVIA Enters into Collaboration with AWS for Next-Generation AI Platform
Wednesday, December 03, 2025IQVIA has announced a new collaboration with Amazon Web Services AWS selecting AWS as its Preferred Agentic Cloud Provider to support the development of its nextgeneration AI platform
Arrowhead Pharmaceuticals Receives Breakthrough Therapy Designation for Plozasiran in Severe Hypertriglyceridaemia
Wednesday, December 03, 2025Arrowhead Pharmaceuticals has received Breakthrough Therapy designation from the US Food and Drug Administration FDA for its investigational therapy plozasiran
Ionis Receives Breakthrough Therapy Designation for Olezarsen for Severe Hypertriglyceridaemia (sHTG)
Tuesday, December 02, 2025Ionis Pharmaceuticals has received Breakthrough Therapy designation from the US Food and Drug Administration FDA for olezarsen an investigational treatment for adults with severe hypertriglyceridaemia sHTG with triglyceride levels of mgdL or higher
Sound Pharmaceuticals Receives Breakthrough Therapy Designation for SPI-1005 for Meniere’s Disease
Tuesday, December 02, 2025Sound Pharmaceuticals SPI has announced that the US Food and Drug Administration FDA has granted Breakthrough Therapy Designation BTD to its investigational drug SPI for the treatment of hearing
Regeneron and Tessera Therapeutics Partner to Develop TSRA-196, an Investigational Gene Editing Therapy for Alpha-1 Antitrypsin Deficiency
Tuesday, December 02, 2025Regeneron Pharmaceuticals and Tessera Therapeutics have entered a global partnership to develop and commercialise TSRA an investigational in vivo Gene Writing therapy for alpha antitrypsin deficiency AATD
Solid Biosciences Receives Rare Pediatric Disease Designation for SGT-212 Gene Therapy for Friedreich’s Ataxia
Tuesday, December 02, 2025Solid Biosciences has received Rare Pediatric Disease designation from the US Food and Drug Administration FDA for SGT its investigational gene therapy being developed for Friedreichs ataxia FA
BeOne Medicines Receives U.S. FDA Priority Review for Sonrotoclax in Relapsed or Refractory Mantle Cell Lymphoma
Thursday, November 27, 2025BeOne Medicines Ltd has announced that the US Food and Drug Administration FDA has granted Priority Review to the New Drug Application for sonrotoclax a nextgeneration BCL inhibitor intended for adult patients
Otsuka Receives Approval for VOYXACT for Reducing Proteinuria in IgA Nephropathy
Thursday, November 27, 2025Otsuka Pharmaceutical has received accelerated approval from the US Food and Drug Administration FDA for VOYXACT sibeprenlimabszsi to reduce proteinuria in adults with primary immunoglobulin A nephropathy IgAN
Prestige Biopharma and Biosidus Forge Exclusive License Agreement for Tuznue® Biosimilar Commercialization Across Latin America
Wednesday, November 26, 2025Singapores Prestige Biopharma enters an exclusive licensing and supply agreement with Biosidus for the commercialization of Tuznue trastuzumab biosimilar in Latin America leveraging advanced manufacturing and crossregional expertise
