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Results For "BLA"

276 News Found

Dr. Reddy's Laboratories launches Versavo in the UK
News | March 19, 2024

Dr. Reddy's Laboratories launches Versavo in the UK

Versavo is the first Dr. Reddy's biosimilar product to be approved and launched in the UK


Biocon Biologics secures US market entry date for Bmab 1200
Drug Approval | March 01, 2024

Biocon Biologics secures US market entry date for Bmab 1200

The agreement licenses the company to launch in the United States, in February 2025, once approved by the U.S. FDA


Moderna posts Q4 2023 revenue at US$ 2.8 billion
News | February 23, 2024

Moderna posts Q4 2023 revenue at US$ 2.8 billion

Net product sales in the fourth quarter of 2023 include the recognition of $0.6 billion from deferred revenue, related to Gavi, the Vaccine Alliance


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


Kokilaben Dhirubhai Ambani Hospital introduces revolutionary HIFU Technology for prostate cancer treatment
Hospitals | January 10, 2024

Kokilaben Dhirubhai Ambani Hospital introduces revolutionary HIFU Technology for prostate cancer treatment

HIFU is a state-of-the-art treatment that utilizes high-frequency sound waves to target and destroy prostate cancer cells


Merck announces Phase 3 trial initiations for 4 Investigational Candidates from hematology and oncology pipeline
Diagnostic Center | January 06, 2024

Merck announces Phase 3 trial initiations for 4 Investigational Candidates from hematology and oncology pipeline

Comprehensive clinical development programs being initiated for each investigational candidate


Alembic Pharmaceuticals received 8 USFDA approvals in Q3FY24
Drug Approval | January 03, 2024

Alembic Pharmaceuticals received 8 USFDA approvals in Q3FY24

The company has received five final approvals


Roche receives USFDA’s priority review to Xolair for food allergies based on positive NIH Phase III study results
Drug Approval | December 26, 2023

Roche receives USFDA’s priority review to Xolair for food allergies based on positive NIH Phase III study results

If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure


USFDA grants priority review for Patritumab Deruxtecan in US for certain patients with EGFR-mutated non-small cell lung cancer
Drug Approval | December 23, 2023

USFDA grants priority review for Patritumab Deruxtecan in US for certain patients with EGFR-mutated non-small cell lung cancer

If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients


FDA grants priority review to Merck’s new biologics license application for V116
Drug Approval | December 20, 2023

FDA grants priority review to Merck’s new biologics license application for V116

V116 is an investigational, 21-valent pneumococcal conjugate vaccine specifically designed to protect adults