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Results For "approval"

2478 News Found

India is the fourth largest medical devices market in Asia: Anupriya Patel
Policy | December 20, 2024

India is the fourth largest medical devices market in Asia: Anupriya Patel

The segment has immense growth potential driven by the country's increasing healthcare needs, technological innovations, government support, and emerging market opportunities


Cipla launches India's first inhalable insulin ‘Afrezza’
News | December 19, 2024

Cipla launches India's first inhalable insulin ‘Afrezza’

Afrezza, developed by MannKind Corporation in the USA, offers a needle-free, rapid-acting insulin option for diabetes management


Zaynich enables US cancer patient undergo successful liver transplant and resume chemotherapy
News | December 17, 2024

Zaynich enables US cancer patient undergo successful liver transplant and resume chemotherapy

In the US, the compassionate use approvals are provided by FDA in the form of individual patient-specific expanded-access IND


Glenmark USA launches Lacosamide Oral Solution, 10 mg/mL
News | December 17, 2024

Glenmark USA launches Lacosamide Oral Solution, 10 mg/mL

According to IQVIATM sales data for the 12-month period ending October 2024, the Vimpat Oral Solution, 10 mg/mL market achieved annual sales of approximately $57.0 million


Bayer announces positive topline resukts for Aflibercept 8 mg in phase III study
Clinical Trials | December 17, 2024

Bayer announces positive topline resukts for Aflibercept 8 mg in phase III study

Demonstrates vision gains with extended treatment intervals in retinal vein occlusion


Pharmaceuticals & Medical Devices Bureau of India partnered with cooperative sector to open Jan Aushadhi Kendras through PACS
Policy | December 16, 2024

Pharmaceuticals & Medical Devices Bureau of India partnered with cooperative sector to open Jan Aushadhi Kendras through PACS

Till 30th November 2024, more than 2690 PACS have been given initial approval and 687 Kendras have been opened in PACS


Acoramidis receives positive CHMP opinion for treatment of transthyretin amyloid cardiomyopathy
Drug Approval | December 14, 2024

Acoramidis receives positive CHMP opinion for treatment of transthyretin amyloid cardiomyopathy

Final decision from the European Commission is anticipated within the coming months


Pfizer announces Phase 3 PATINA study in patients with HR+, HER2+ metastatic breast cancer
News | December 13, 2024

Pfizer announces Phase 3 PATINA study in patients with HR+, HER2+ metastatic breast cancer

IBRANCE is the first CDK4/6 inhibitor to show benefit in a large Phase 3 trial in first-line HR+, HER2+ metastatic breast cancer, in combination with anti-HER2 and endocrine therapy


Metropolis Healthcare acquires Core Diagnostics for Rs. 246.8 Cr
Clinical Trials | December 09, 2024

Metropolis Healthcare acquires Core Diagnostics for Rs. 246.8 Cr

Aims to become India’s leading cancer testing company


FDA RMAT status for Affimed and Artiva’s lymphoma combo therapy
Drug Approval | December 07, 2024

FDA RMAT status for Affimed and Artiva’s lymphoma combo therapy

Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients