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3337 News Found

EU approves Alexion’s Koselugo to treat adults with neurofibromatosis type 1 tumours
Clinical Trials | October 31, 2025

EU approves Alexion’s Koselugo to treat adults with neurofibromatosis type 1 tumours

Approval based on pivotal KOMET Phase III trial demonstrating significant tumour reduction in adults with NF1


Alexion highlights breakthrough C5 inhibition advances in gMG at 2025 AANEM and MGFA scientific sessions
Clinical Trials | October 31, 2025

Alexion highlights breakthrough C5 inhibition advances in gMG at 2025 AANEM and MGFA scientific sessions

New Phase III data on gefurulimab highlight potential as a self-administered treatment option; real-world evidence reinforces clinical benefits of Ultomiris and Soliris


Granules India’s facility secures FDA EIR with 'VAI’
Drug Approval | October 30, 2025

Granules India’s facility secures FDA EIR with 'VAI’

The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025


Lilly to invest $1.2 billion+ to boost oral medicine manufacturing capacity in US
News | October 30, 2025

Lilly to invest $1.2 billion+ to boost oral medicine manufacturing capacity in US

Company plans to create 100 manufacturing jobs and up to 1,000 construction jobs


Roche receives CE mark for novel automated high-throughput Elecsys Dengue Ag test
News | October 30, 2025

Roche receives CE mark for novel automated high-throughput Elecsys Dengue Ag test

Test delivers results in just 18 minutes, enabling faster laboratory workflows and patient management during outbreaks


AskBio’s gene therapy shows promising 12-month results for heart failure
Biotech | October 29, 2025

AskBio’s gene therapy shows promising 12-month results for heart failure

Results demonstrate favorable safety profile and clinically meaningful improvements in patients with non-ischemic heart failure


FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma
Drug Approval | October 29, 2025

FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma

The Fast Track Designation was supported by nonclinical data as well as clinical results from the ongoing Phase I/IIa trial evaluating the safety and tolerability


Novartis completes acquisition of Tourmaline Bio
News | October 29, 2025

Novartis completes acquisition of Tourmaline Bio

Tourmaline is now an indirect wholly owned subsidiary of Novartis


Sai Life Sciences to double process R&D capacity with new facility in Hyderabad
R&D | October 28, 2025

Sai Life Sciences to double process R&D capacity with new facility in Hyderabad

The new CMC Process R&D Center represents a strategic investment in scale, sustainability, and specialization