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1522 News Found

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


Roche’s Gazyva shows strong phase III results for treatment of idiopathic nephrotic syndrome
Clinical Trials | October 30, 2025

Roche’s Gazyva shows strong phase III results for treatment of idiopathic nephrotic syndrome

Key secondary endpoints also demonstrated statistically significant and clinically meaningful benefits with Gazyva


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


FDA approves Bayer’s Lynkuet as first hormone-free therapy for menopausal hot flashes
Drug Approval | October 29, 2025

FDA approves Bayer’s Lynkuet as first hormone-free therapy for menopausal hot flashes

This approval marks a significant milestone in women’s health, introducing Bayer’s first hormone-free treatment for menopause-related symptoms


MIRA Pharmaceuticals advances oral Ketamir-2 into Phase 1 MAD study for chemotherapy-induced neuropathic pain
Clinical Trials | October 29, 2025

MIRA Pharmaceuticals advances oral Ketamir-2 into Phase 1 MAD study for chemotherapy-induced neuropathic pain

Advancing toward Phase 2a evaluation in chemotherapy-related pain, a condition with no approved treatments and potential for FDA Fast Track designation


Orion secures license to Abzena’s next-generation cancer antibody
R&D | October 29, 2025

Orion secures license to Abzena’s next-generation cancer antibody

The antibody was designed and developed at Abzena’s Cambridge, UK,


Akums breaks ground for its first overseas manufacturing facility in Zambia
News | October 28, 2025

Akums breaks ground for its first overseas manufacturing facility in Zambia

It will produce a comprehensive range of dosage forms including tablets, hard gelatin capsules, liquids, injectables, topicals, and beta-lactam products


GSK acquires rights to prostate-cancer candidate from Syndivia for up to £268 million
Biotech | October 27, 2025

GSK acquires rights to prostate-cancer candidate from Syndivia for up to £268 million

Agreement adds a new preclinical ADC with potential for enhanced anti-tumour activity and best-in-class profile


Sanofi’s Efdoralprin Alfa shows superiority in phase 2 Alpha-1 antitrypsin deficiency study
Clinical Trials | October 25, 2025

Sanofi’s Efdoralprin Alfa shows superiority in phase 2 Alpha-1 antitrypsin deficiency study

Efdoralprin Alfa was well tolerated, with a safety profile comparable to plasma-derived therapy