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Results For "adult"

1344 News Found

Zydus receives final approval and 180 days shared exclusivity from USFDA for Brexpiprazole tablets
Drug Approval | January 13, 2023

Zydus receives final approval and 180 days shared exclusivity from USFDA for Brexpiprazole tablets

Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults


Lupin and Exeltis announce reimbursement approval of NaMuscla in Spain
News | January 10, 2023

Lupin and Exeltis announce reimbursement approval of NaMuscla in Spain

NDM disorders are a group of rare, inherited neuromuscular disorders with an estimated prevalence of 1 case per 100,000 inhabitants in Spain, and are characterized by the inability to relax muscles following voluntary contraction (myotonia)


Alembic receives USFDA final approval for Fesoterodine Fumarate Extended-Release Tablets
Drug Approval | January 07, 2023

Alembic receives USFDA final approval for Fesoterodine Fumarate Extended-Release Tablets

Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, have an estimated market size of US$ 177 million for twelve months ending Sep 2022


InnoCare get approval of Tafasitamab with Lenalidomide for the treatment of refractory diffuse large B-Cell lymphoma in Hong Kong
Drug Approval | December 31, 2022

InnoCare get approval of Tafasitamab with Lenalidomide for the treatment of refractory diffuse large B-Cell lymphoma in Hong Kong

Tafasitamab is conditionally approved by both the U.S. Food and Drug Administration and European Medicines Agency


USFDA accepts for review the biologics license application for Pfizer’s Investigational MenABCWY in adolescents
Drug Approval | December 31, 2022

USFDA accepts for review the biologics license application for Pfizer’s Investigational MenABCWY in adolescents

If approved, the vaccine could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine


CDSCO and State Drugs Control Administration commence joint inspection of drug manufacturing units
Policy | December 28, 2022

CDSCO and State Drugs Control Administration commence joint inspection of drug manufacturing units

A committee of two Joint Drugs Controllers has been constituted at CDSCO to monitor the process of inspection, reporting, and subsequent action to ensure compliance to the Drugs & Cosmetics Act, 1940


Zydus receives final approval and 180 days shared exclusivity from USFDA for Selexipag Tablets
Drug Approval | December 23, 2022

Zydus receives final approval and 180 days shared exclusivity from USFDA for Selexipag Tablets

Selexipag tablet is indicated in adults for the treatment of pulmonary arterial hypertension to delay disease progression and reduce the risk of hospitalization for PAH


Lynparza in combination with Abiraterone and Prednisone approved in the EU as treatment for metastatic castration-resistant prostate cancer
Clinical Trials | December 22, 2022

Lynparza in combination with Abiraterone and Prednisone approved in the EU as treatment for metastatic castration-resistant prostate cancer

First PARP inhibitor and new hormonal agent combination approved for these patients in Europe