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1155 News Found

Cellenkos scores FDA orphan drug designation for CK0804 in rare blood cancer
Drug Approval | January 08, 2026

Cellenkos scores FDA orphan drug designation for CK0804 in rare blood cancer

Receiving Orphan Drug Designation is an important milestone in the clinical development of CK0804 for myelofibrosis


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


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


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


Wegovy pill marks first GLP-1 weight-loss medicine in oral form
News | January 06, 2026

Wegovy pill marks first GLP-1 weight-loss medicine in oral form

The approval introduces a needle-free alternative to injectable GLP-1 therapies


RedHill Biopharma advances RHB-102 as once-daily oral therapy to combat GLP-1 side effects
Clinical Trials | January 06, 2026

RedHill Biopharma advances RHB-102 as once-daily oral therapy to combat GLP-1 side effects

The company is pursuing the accelerated FDA 505(b)(2) approval pathway for its once-daily oral ondansetron formulation


Singapore clears AI bladder cancer detection tool
News | January 06, 2026

Singapore clears AI bladder cancer detection tool

CystoSmart, an AI tool designed to detect bladder tumors during screening and surveillance cystoscopy, is brand-agnostic and works with flexible, rigid, and single-use scopes


FDA nod to first-ever treatment for deadly post-transplant complication TA-TMA
Drug Approval | January 05, 2026

FDA nod to first-ever treatment for deadly post-transplant complication TA-TMA

The decision positions Yartemlea as the first and only approved inhibitor of the lectin pathway of complement


BioVarta 2025 puts the spotlight on translating biotech innovation into impact
News | January 04, 2026

BioVarta 2025 puts the spotlight on translating biotech innovation into impact

Leaders from science, policy, industry, and investment came together in New Delhi to examine how alignment across the biotechnology value chain can turn innovation into outcomes at scale


HUTCHMED’s Fanregratinib gains priority review in China for aggressive liver cancer
News | January 01, 2026

HUTCHMED’s Fanregratinib gains priority review in China for aggressive liver cancer

ICC is a highly aggressive liver cancer arising from the intrahepatic biliary epithelium