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3407 News Found

Eugia Pharma receives USFDA approval for Vasopressin Injection USP
Drug Approval | August 16, 2022

Eugia Pharma receives USFDA approval for Vasopressin Injection USP

The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA.


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)


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


Arbitrator rules in favor of Daiichi Sankyo in dispute with Seagen
News | August 15, 2022

Arbitrator rules in favor of Daiichi Sankyo in dispute with Seagen

All claims made by Seagen regarding Daiichi Sankyo antibody drug conjugates are denied


ENHERTU delays disease progression in DESTINYBreast02 Phase 3 Trial
Clinical Trials | August 15, 2022

ENHERTU delays disease progression in DESTINYBreast02 Phase 3 Trial

Results consistent with previous trials, reinforcing benefit of Daiichi Sankyo and AstraZeneca’s ENHERTU in previously treated patients


Lupin receives USFDA approval for Meclizine Hydrochloride Tablets USP
Drug Approval | August 13, 2022

Lupin receives USFDA approval for Meclizine Hydrochloride Tablets USP

The product will be manufactured at Lupin’s facility in Goa, India.


Roche gets USFDA approval of Xofluza to treat influenza in children
Drug Approval | August 13, 2022

Roche gets USFDA approval of Xofluza to treat influenza in children

Xofluza is the first and only single-dose oral medicine for the treatment of influenza to be approved in the US for children as young as five years of age


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


MoU signed between Ministry of Ayush and MeitY
Policy | August 13, 2022

MoU signed between Ministry of Ayush and MeitY

MeitY will provide technical support for digitalisation of the Ayush Sector under the Ayush Grid project for a period of three years