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5494 News Found

Bayer’s Sevabertinib gets green light from FDA and China for advanced lung cancer
Drug Approval | January 08, 2026

Bayer’s Sevabertinib gets green light from FDA and China for advanced lung cancer

Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that directly targets HER2 mutations


Stereotaxis scores FDA nod for groundbreaking MAGiC robotic heart catheter
Medical Device | January 08, 2026

Stereotaxis scores FDA nod for groundbreaking MAGiC robotic heart catheter

The MAGiC catheter is designed for robotically-navigated cardiac ablation procedures


Arrowhead Pharmaceuticals gets green light for first-of-its-kind FCS therapy
News | January 08, 2026

Arrowhead Pharmaceuticals gets green light for first-of-its-kind FCS therapy

REDEMPLO is the first and only Health Canada-approved siRNA therapy for FCS


Wockhardt files marketing authorisation application for WCK 5222 with EMA
News | January 08, 2026

Wockhardt files marketing authorisation application for WCK 5222 with EMA

WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation


ProBioGen, Zag Bio seal manufacturing deal to fast-track type 1 diabetes therapy into clinic
Biotech | January 07, 2026

ProBioGen, Zag Bio seal manufacturing deal to fast-track type 1 diabetes therapy into clinic

The work will leverage ProBioGen’s CHO.RiGHT expression platform, powered by its proprietary DirectedLuck transposase technology, alongside PsiBot smart automation


Subcutaneous Saphnelo cuts lupus disease activity in phase III trial
Biopharma | January 07, 2026

Subcutaneous Saphnelo cuts lupus disease activity in phase III trial

SLE remains a life-threatening autoimmune disease, with patients facing an elevated risk of early mortality and long-term organ damage


FDA grants priority review to Tzield for youngest Type 1 diabetes patients
Drug Approval | January 07, 2026

FDA grants priority review to Tzield for youngest Type 1 diabetes patients

Currently approved for patients eight and older, Tzield could now be used to delay the onset of stage 3 type 1 diabetes (T1D) in children diagnosed with stage 2 T1D


GSK’s Nucala approved in China for COPD with high eosinophils
Drug Approval | January 07, 2026

GSK’s Nucala approved in China for COPD with high eosinophils

Mepolizumab is the first and only monthly biologic in China tested for COPD patients with blood eosinophil counts (BEC) as low as 150 cells/µL


Medera doses final patient in high-dose HFpEF gene therapy trial
Biopharma | January 07, 2026

Medera doses final patient in high-dose HFpEF gene therapy trial

Heart failure affects an estimated 64.3 million people worldwide


Merck completes acquisition of Cidara Therapeutics
News | January 07, 2026

Merck completes acquisition of Cidara Therapeutics

Cidara will become a wholly owned subsidiary of Merck and the common stock of Cidara will no longer be listed or traded on the Nasdaq Global Market