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3160 News Found

FDA accepts submission of olaparib in combination with abiraterone and prednisone for prostate cancer
Drug Approval | August 17, 2022

FDA accepts submission of olaparib in combination with abiraterone and prednisone for prostate cancer

First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations


Wockhardt announces successful initiation of Global Phase 3 Clinical Study of its novel antibiotic WCK 5222
Diagnostic Center | August 16, 2022

Wockhardt announces successful initiation of Global Phase 3 Clinical Study of its novel antibiotic WCK 5222

WCK 5222 is a Super-drug which is entirely a new class of antibiotic known as "?-lactam ENHANCER".


Lupin receives approval from U.S. FDA for Meclizine Hydrochloride Tablets USP
Drug Approval | August 16, 2022

Lupin receives approval from U.S. FDA for Meclizine Hydrochloride Tablets USP

Meclizine Hydrochloride Tablets had estimated annual sales of USD 29 million in the U.S.


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
Diagnostic Center | 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