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Results For "Orbis"

13 News Found

Orbis India Partners Meet 2026 focuses on sustainable, climate-resilient eye care
Hospitals | April 13, 2026

Orbis India Partners Meet 2026 focuses on sustainable, climate-resilient eye care

Green Vision Centres cut emissions, expand community coverage as partners align on resilient eye health systems


FDA fast-tracks Daiichi Sankyo & Merck lung cancer drug review
Drug Approval | April 14, 2026

FDA fast-tracks Daiichi Sankyo & Merck lung cancer drug review

The FDA is also reviewing the application under its Real-Time Oncology Review (RTOR) program and Project Orbis


FDA grants priority review to Enhertu for high-risk HER2-positive breast cancer
News | March 10, 2026

FDA grants priority review to Enhertu for high-risk HER2-positive breast cancer

Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population


FDA grants priority review to Bristol Myers Squibb's Iberdomide for multiple myeloma
Drug Approval | February 17, 2026

FDA grants priority review to Bristol Myers Squibb's Iberdomide for multiple myeloma

Iberdomide has the potential to be the first approved CELMoD agent


AstraZeneca & Daiichi Sankyo gain priority review for Datroway in hard-to-treat breast cancer
News | February 05, 2026

AstraZeneca & Daiichi Sankyo gain priority review for Datroway in hard-to-treat breast cancer

The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)


FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer
Drug Approval | November 21, 2025

FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer

HER2-mutant NSCLC typically has a poor prognosis and limited treatment options


Calquence combination approved in US for untreated mantle cell lymphoma
Drug Approval | January 18, 2025

Calquence combination approved in US for untreated mantle cell lymphoma

Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone


Calquence granted priority review in US for patients with untreated mantle cell lymphoma
Drug Approval | October 06, 2024

Calquence granted priority review in US for patients with untreated mantle cell lymphoma

Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy


Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours
Drug Approval | January 31, 2024

Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours

Submission to be reviewed under FDA real-time oncology review and Project Orbis