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452 News Found

FDA approves sBLA for Takeda's Vonvendi for Von Willebrand disease
Drug Approval | September 08, 2025

FDA approves sBLA for Takeda's Vonvendi for Von Willebrand disease

Vonvendi is the only recombinant Von Willebrand factor replacement therapy with approved indications in adults and children with VWD


FDA approves Lecanemab autoinjector, marking first at-home treatment for Alzheimer disease
Drug Approval | September 02, 2025

FDA approves Lecanemab autoinjector, marking first at-home treatment for Alzheimer disease

The new subcutaneous autoinjector for lecanemab offers a self-administered, at-home treatment option for early-stage Alzheimer's disease


Novo Nordisk taps Replicate Bioscience’s srRNA platform for obesity
News | August 31, 2025

Novo Nordisk taps Replicate Bioscience’s srRNA platform for obesity

Replicate will receive research funding and could potentially receive up to approximately US$550 million


Accro Bioscience and Fosun Pharma ink agreement for TYK2/JAK1 Inhibitor in Greater China
News | August 30, 2025

Accro Bioscience and Fosun Pharma ink agreement for TYK2/JAK1 Inhibitor in Greater China

Accro will retain global rights to develop, manufacture, and commercialize AC-201 (excluding Chinese Mainland, Hong Kong SAR, and Macau SAR)


Moderna receives FDA approval for updated COVID-19 vaccines for LP.8.1 Variant of SARS-CoV-2
Drug Approval | August 29, 2025

Moderna receives FDA approval for updated COVID-19 vaccines for LP.8.1 Variant of SARS-CoV-2

The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age


argenx reports positive phase 3 ADAPT SERON results of VYVGART in AChR-Ab seronegative gMG
News | August 28, 2025

argenx reports positive phase 3 ADAPT SERON results of VYVGART in AChR-Ab seronegative gMG

VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications


Boehringer and AnGes sign manufacturing agreement for HGF gene therapy product
Biotech | August 25, 2025

Boehringer and AnGes sign manufacturing agreement for HGF gene therapy product

Collaboration reinforces Boehringer Ingelheim’s expertise in microbial contract development and manufacturing


Illumina launches new assay for tumor profiling
News | August 03, 2025

Illumina launches new assay for tumor profiling

he new version features a streamlined sample-to-analysis workflow, built-in HRD detection, faster turnaround, and lower tissue requirements


Johnson & Johnson submits additional data to FDA on psoriatic arthritis
News | August 03, 2025

Johnson & Johnson submits additional data to FDA on psoriatic arthritis

The submission is supported by results from the Phase 3b APEX study