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Results For "FDA"

2061 News Found

Lupin launches Desvenlafaxine extended-release tablets in the US
News | August 27, 2022

Lupin launches Desvenlafaxine extended-release tablets in the US

Desvenlafaxine Extended-Release Tablets, 25 mg is a generic equivalent of Pristiq Extended-Release Tablets, 25 mg of PF PRISM C.V.


Unichem Laboratories receives ANDA approval for Carbamazepine Tablets
Drug Approval | August 24, 2022

Unichem Laboratories receives ANDA approval for Carbamazepine Tablets

Carbamazepine Tablets are indicated for use as an anticonvulsant drug and in the treatment of the pain associated with true trigeminal neuralgia


Ascletis announces IND approval of Oral RdRp Inhibitor ASC10 for COVID-19 by China NMPA
Drug Approval | August 22, 2022

Ascletis announces IND approval of Oral RdRp Inhibitor ASC10 for COVID-19 by China NMPA

Ascletis is China's first biotech company which has obtained IND approvals of an oral RdRp inhibitor from both China NMPA and the U.S. FDA


Swissmedic approves Kapruvia with additional regulatory decisions expected in H2 2022
Drug Approval | August 20, 2022

Swissmedic approves Kapruvia with additional regulatory decisions expected in H2 2022

Therapy recently approved in Canada under the brand name KORSUVA


NATCO announces tentative approval to its ANDA for Trabectedin
Drug Approval | August 18, 2022

NATCO announces tentative approval to its ANDA for Trabectedin

According to industry sales data, Yondelis generated annual sales of $49.7 million for the twelve months ending June 2022 in the US market.


Fish & Richardson secures win for Exela Pharma Sciences in ELCYS patent infringement litigation
News | August 16, 2022

Fish & Richardson secures win for Exela Pharma Sciences in ELCYS patent infringement litigation

ELCYS is the only FDA-approved cysteine hydrochloride injection on the market for use as an additive to amino acid solutions


Unichem receives ANDA approval for quetiapine extended-release tablets
Drug Approval | August 16, 2022

Unichem receives ANDA approval for quetiapine extended-release tablets

Quetiapine Extended-Release Tablets are indicated for the treatment of Schizophrenia, Bipolar disorder and adjunctive treatment of Major Depressive Disorder (MDD)


PharmaCyte Biotech reaches cooperation agreement with Iroquois Capital
Biotech | August 16, 2022

PharmaCyte Biotech reaches cooperation agreement with Iroquois Capital

Company appoints five new independent directors to reconstituted board


Pfizer announces positive results from Phase 3 study of 20-valent pneumococcal conjugate vaccine
Clinical Trials | August 13, 2022

Pfizer announces positive results from Phase 3 study of 20-valent pneumococcal conjugate vaccine

Pfizer plans to submit an sBLA by the end of this year, subject to discussions with U.S. FDA


Enhertu approved in the US as the first HER2-directed therapy for patients with previously treated HER2-mutant metastatic non-small cell lung cancer
News | August 13, 2022

Enhertu approved in the US as the first HER2-directed therapy for patients with previously treated HER2-mutant metastatic non-small cell lung cancer

Based on DESTINY-Lung02 results which showed AstraZeneca and Daiichi Sankyo’s Enhertu reported a confirmed objective response rate of 57.7% in patients with HER2-mutant disease