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Results For "FDA-approval"

460 News Found

USFDA Advisory Committee votes  n Lynparza plus Abiraterone and Prednisone  for prostate cancer
Drug Approval | May 03, 2023

USFDA Advisory Committee votes n Lynparza plus Abiraterone and Prednisone for prostate cancer

The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients


Inflation and declining FDA drug approvals will pose challenges for pharma contract manufacturers in 2023, says GlobalData
News | April 08, 2023

Inflation and declining FDA drug approvals will pose challenges for pharma contract manufacturers in 2023, says GlobalData

FDA’s NME approvals declined substantially in 2022, causing overall New Drug Application (NDA) approvals to drop


GSK and SCYNEXIS announce agreement to commercialise and further develop Brexafemme
News | April 03, 2023

GSK and SCYNEXIS announce agreement to commercialise and further develop Brexafemme

SCYNEXIS will receive an upfront payment of $90 million with future performance-based milestone payments and tiered royalties


Granules India inaugurates packaging facility in Virginia
Supply Chain | March 30, 2023

Granules India inaugurates packaging facility in Virginia

The facility is over 79,000 square feet and is equipped with packaging lines


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


Provention Bio appoints Rita Jain to Board of Directors
People | January 06, 2023

Provention Bio appoints Rita Jain to Board of Directors

Dr. Jain is a biotechnology industry veteran with more than two decades of experience in pharmaceutical development across her time with ChemoCentryx, AbbVie, Abbott Laboratories, and G.D. Searle and Co


Briefs: Gland Pharma, Supriya Lifescience, Hindustan Unilever and Eugia Pharma
Drug Approval | January 05, 2023

Briefs: Gland Pharma, Supriya Lifescience, Hindustan Unilever and Eugia Pharma

Supriya Lifescience Limited has informed that the European Directorate for the Quality of Medicines (EDQM) has granted Attestation of Inspection (EU-GMP) for Lote API Facility, Ratnagiri, Maharashtra.


Aptar Pharma collaborates with Fluidda
News | September 25, 2022

Aptar Pharma collaborates with Fluidda

The companies will leverage their respective proprietary technology platforms


Zydus receives final approval from USFDA for Lenalidomide Capsules
Drug Approval | September 15, 2022

Zydus receives final approval from USFDA for Lenalidomide Capsules

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India