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Results For "approval"

2476 News Found

Janssen and Eli Lilly collaboration to address lack of pediatric therapies could rescue mirikizumab program, says GlobalData
News | February 06, 2023

Janssen and Eli Lilly collaboration to address lack of pediatric therapies could rescue mirikizumab program, says GlobalData

The agreement between Eli Lilly and Janssen was established to allow the two companies to share resources for the goal of accelerating the evaluation of the respective companies’ assets, mirikizumab and Tremfya (guselkumab).


Sun Pharma Q3 FY23 Gross Sales up 13.1%; Net profit up 5.2%
News | February 01, 2023

Sun Pharma Q3 FY23 Gross Sales up 13.1%; Net profit up 5.2%

India formulation sales at Rs. 3,391.9 crore, up 7.1% over Q3 last year


CHMP recommends Bayer’s darolutamide for the treatment of metastatic hormone-sensitive prostate cancer
Drug Approval | January 31, 2023

CHMP recommends Bayer’s darolutamide for the treatment of metastatic hormone-sensitive prostate cancer

CHMP recommendation is based on Phase III data, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5%


Global diagnostic imaging market to reach $31.9 billion in 2023: GlobalData
Clinical Trials | January 31, 2023

Global diagnostic imaging market to reach $31.9 billion in 2023: GlobalData

Diagnostic imaging will become an increasingly vital process in healthcare


FDA approves Keytruda as adjuvant treatment for non-small cell lung cancer
Drug Approval | January 30, 2023

FDA approves Keytruda as adjuvant treatment for non-small cell lung cancer

Approval marks fifth indication for KEYTRUDA-based regimens in NSCLC and 34th indication for KEYTRUDA in the US


USFDA inspection: Zydus Lifesciences and Gland Pharma
Drug Approval | January 28, 2023

USFDA inspection: Zydus Lifesciences and Gland Pharma

The United States Food and Drug Administration (USFDA) conducted an inspection at Gland Pharma Limited API Facility at JNPC, Visakhapatnam


Dr. Reddy's Laboratories launches Difluprednate Ophthalmic Emulsion 0.05% in US
News | January 28, 2023

Dr. Reddy's Laboratories launches Difluprednate Ophthalmic Emulsion 0.05% in US

The Durezol brand and generic had US sales of approximately US $40 million MAT for the most recent twelve months ending in Nov 2022 according to IQVIA


Pharma companies developing vaccines with efficacy against Omicron variants will gain competitive advantage in China, says GlobalData
News | January 27, 2023

Pharma companies developing vaccines with efficacy against Omicron variants will gain competitive advantage in China, says GlobalData

The WHO has urged China to increase adoption of mRNA vaccines, given their high efficacy against variant strains.


Moderna announces an investigational respiratory syncytial vaccine mRNA-1345
News | January 23, 2023

Moderna announces an investigational respiratory syncytial vaccine mRNA-1345

mRNA-1345 demonstrated vaccine efficacy of 83.7% against RSV lower respiratory tract disease, defined by 2 or more symptoms in older adults


Dr. Reddy’s completes clinical studies of its rituximab biosimilar for filing in the U.S., Europe
Drug Approval | January 21, 2023

Dr. Reddy’s completes clinical studies of its rituximab biosimilar for filing in the U.S., Europe

Following successful completion of full set of clinical studies of proposed rituximab biosimilar candidate DRL_RI, Dr. Reddy’s will now prepare to file in the United States, European Union and other regions