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1238 News Found

Edwards Lifesciences’ SAPIEN M3 becomes first FDA-approved transseptal mitral valve replacement
Medical Device | December 27, 2025

Edwards Lifesciences’ SAPIEN M3 becomes first FDA-approved transseptal mitral valve replacement

The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system is designed for patients with symptomatic moderate-to-severe or severe MR


Japan nod to Dupixent for children with severe asthma
Drug Approval | December 26, 2025

Japan nod to Dupixent for children with severe asthma

The decision is based on robust clinical evidence from the VOYAGE and EXCURSION studies


Lunit SCOPE matches pathologist accuracy in HER2 scoring for advanced biliary tract cancer
Clinical Trials | December 25, 2025

Lunit SCOPE matches pathologist accuracy in HER2 scoring for advanced biliary tract cancer

Study published in laboratory investigation, the official journal of the United States and Canadian Academy of Pathology


Tanabe Pharma America transfers RADICAVA business to Shionogi
News | December 25, 2025

Tanabe Pharma America transfers RADICAVA business to Shionogi

U.S. and Canada transaction supports continued access to RADICAVA for people living with ALS


Ipsen acquires Simcere Zaiming’s innovative ADC SIM0613
Biopharma | December 24, 2025

Ipsen acquires Simcere Zaiming’s innovative ADC SIM0613

The therapy targets the LRRC15 protein and is designed for enhanced tumor penetration and differentiated anti-tumor activity in solid tumors with the highest unmet needs.


Gilead licenses Assembly Bio's investigational Herpes drugs after positive phase 1b data
Clinical Trials | December 24, 2025

Gilead licenses Assembly Bio's investigational Herpes drugs after positive phase 1b data

Under the 2023 collaboration agreement, Assembly Bio will receive $35 million for Gilead’s exercise of the HSV program option


LATIFY Phase III trial of Ceralasertib fails to improve survival in advanced lung cancer
Clinical Trials | December 23, 2025

LATIFY Phase III trial of Ceralasertib fails to improve survival in advanced lung cancer

The study focused on patients without actionable genomic alterations whose disease had progressed after prior immunotherapy and platinum-based chemotherapy


Zambon Biotech launches European Phase 3b trial for innovative Parkinson’s drug
Clinical Trials | December 23, 2025

Zambon Biotech launches European Phase 3b trial for innovative Parkinson’s drug

The trial will evaluate the efficacy and safety of IPX203 versus immediate-release levodopa/carbidopa


Biocon inks out-licensing agreement with Ajanta to market Semaglutide in 26 countries
News | December 23, 2025

Biocon inks out-licensing agreement with Ajanta to market Semaglutide in 26 countries

Biocon will be responsible for supplying Semaglutide to Ajanta for exclusive marketing in 23 countries and semi-exclusive marketing in 3 countries across Africa, Middle East and Central Asia


Zydus Partners with Bioeq for US commercialisation rights for Nufymco
News | December 23, 2025

Zydus Partners with Bioeq for US commercialisation rights for Nufymco

NUFYMCO BLA has been approved by the USFDA