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3149 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


Godavari Biorefineries launches US biotech arm to advance novel cancer therapies
News | December 18, 2025

Godavari Biorefineries launches US biotech arm to advance novel cancer therapies

The move strengthens GBL’s clinical-stage presence in the United States


Alphyn Biologics bags $25 million financing to advance breakthrough skin disease therapies
News | December 16, 2025

Alphyn Biologics bags $25 million financing to advance breakthrough skin disease therapies

Alphyn is developing Zabalafin Hydrogel as the first therapy to simultaneously tackle the interconnected drivers of AD


Indoco receives EIR from the USFDA for its API manufacturing facility at Patalganga
News | December 15, 2025

Indoco receives EIR from the USFDA for its API manufacturing facility at Patalganga

Indoco received the Establishment Inspection Report from the USFDA for its API manufacturing facility


Apitoria Pharma receives 3 observations from USFDA for Unit-V
Drug Approval | December 12, 2025

Apitoria Pharma receives 3 observations from USFDA for Unit-V

The company will respond to the US FDA within the stipulated timelines


Pharvaris’ deucrictibant shows rapid relief for hereditary angioedema in pivotal Phase 3 trial
Clinical Trials | December 09, 2025

Pharvaris’ deucrictibant shows rapid relief for hereditary angioedema in pivotal Phase 3 trial

The study met its primary endpoint and all 11 secondary efficacy endpoints


Kytopen & TQ Therapeutics forge partnership to advance next-generation cell therapies
Technology | December 04, 2025

Kytopen & TQ Therapeutics forge partnership to advance next-generation cell therapies

The partnership aims to combine TQx’s in vivo therapeutic expertise with Kytopen’s continuous flow transfection technology


Roche launches first rapid point-of-care test for whooping cough
News | December 04, 2025

Roche launches first rapid point-of-care test for whooping cough

The PCR-based test, delivered via Roche’s cobas liat system, allows results to be obtained during a patient consultation in GP practices and Emergency Rooms


WHO urges rapid expansion of new HIV prevention tools amid funding crisis
Healthcare | December 03, 2025

WHO urges rapid expansion of new HIV prevention tools amid funding crisis

Despite steep funding setbacks, the global HIV response has gained momentum in 2025 with the introduction of twice-yearly injectable LEN


Ovation.io and PrecisionLife team to develop drug-response biomarkers for GLP-1 therapies
R&D | November 28, 2025

Ovation.io and PrecisionLife team to develop drug-response biomarkers for GLP-1 therapies

GLP-1 therapies are among the fastest-growing drug classes worldwide, projected to drive a $95 billion obesity market by 2030