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Results For "U.S"

1563 News Found

Biocon Biologics gets complete response letter from USFDA for Biosimilar Insulin Aspart
Drug Approval | October 09, 2023

Biocon Biologics gets complete response letter from USFDA for Biosimilar Insulin Aspart

The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022


Lupin receives tentative approval from USFDA for Tolvaptan Tablets
Drug Approval | October 07, 2023

Lupin receives tentative approval from USFDA for Tolvaptan Tablets

Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)


Alembic received 6 USFDA approvals during Q2FY24
Drug Approval | October 05, 2023

Alembic received 6 USFDA approvals during Q2FY24

The company has received six final approvals that includes Chlorpromazine Hydrochloride Tablets


USFDA delegation visits Divi's Laboratories’ Unit I at Choutuppal, Telangana
Drug Approval | September 29, 2023

USFDA delegation visits Divi's Laboratories’ Unit I at Choutuppal, Telangana

The delegation's visit covered a wide range of topics


Cosmo and Glenmark sign distribution and license agreements for Winlevi in Europe and South Africa
Supply Chain | September 28, 2023

Cosmo and Glenmark sign distribution and license agreements for Winlevi in Europe and South Africa

Glenmark will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to commercialize Winlevi in 15 EU countries


Merck receives positive EU CHMP opinion for Keytruda as adjuvant treatment for  cell lung cancer
Drug Approval | September 18, 2023

Merck receives positive EU CHMP opinion for Keytruda as adjuvant treatment for cell lung cancer

Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial


Sun Pharma and Pharmazz ink agreement for introducing Tyvalzi in India
News | September 15, 2023

Sun Pharma and Pharmazz ink agreement for introducing Tyvalzi in India

Sun Pharma is granted rights for marketing Sovateltide in India under the brand name Tyvalzi (Sovateltide)


Aptar appoints Sarah Glickman to its Board of Directors
People | September 07, 2023

Aptar appoints Sarah Glickman to its Board of Directors

Sarah currently serves as the Chief Financial Officer and Principal Accounting Officer for Criteo S.A.


Insmed announces positive results from Phase III arise study of ARIKAYCE
News | September 06, 2023

Insmed announces positive results from Phase III arise study of ARIKAYCE

Patients Treated with ARIKAYCE plus macrolide-based background regimen had meaningfully larger improvements in QOL-B respiratory score