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6641 News Found

EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis
News | December 05, 2022

EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis

Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints


Zydus receives final approval from USFDA for Estradiol Transdermal System
Drug Approval | December 05, 2022

Zydus receives final approval from USFDA for Estradiol Transdermal System

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad


Mirati Therapeutics announces update for the Phase 3 SAPPHIRE study
News | December 05, 2022

Mirati Therapeutics announces update for the Phase 3 SAPPHIRE study

Evaluating Investigational Sitravatinib in combination with Nivolumab for patients with non-squamous non-small cell lung cancer


Zydus receives final approval from USFDA for Topiramate Extended-Release capsules
Drug Approval | December 02, 2022

Zydus receives final approval from USFDA for Topiramate Extended-Release capsules

Topiramate Extended-Release capsule had annual sales of US $68.8 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022)


World’s first intra-nasal vaccine for COVID developed by India has got approval from CDSCO
News | December 02, 2022

World’s first intra-nasal vaccine for COVID developed by India has got approval from CDSCO

Phase-III trials were conducted for safety, and immunogenicity in around 3,100 subjects, in 14 trial sites across India (supported by BIRAC)


Alembic receives USFDA final approval for Diclofenac Sodium Topical Solution USP
Drug Approval | December 02, 2022

Alembic receives USFDA final approval for Diclofenac Sodium Topical Solution USP

Diclofenac Sodium Topical Solution USP, 2% w/w has an estimated market size of US $512 million for twelve months ending Sep 2022 according to IQVIA


Akums partners with Leiutis and Biophore for developing products for multiple therapies
News | December 01, 2022

Akums partners with Leiutis and Biophore for developing products for multiple therapies

The focus of the companies in this partnership is to synergise capabilities, leverage research and bring innovative products in specific therapeutic areas


JB Pharma gets USFDA approval for its generic Venlafaxine Extended-Release Tablets
Drug Approval | December 01, 2022

JB Pharma gets USFDA approval for its generic Venlafaxine Extended-Release Tablets

This product is based on Osmotic Controlled Release Oral Delivery System technology


AstraZeneca’s Dapagliflozin receives CDSCO approval
Drug Approval | November 30, 2022

AstraZeneca’s Dapagliflozin receives CDSCO approval

Dapagliflozin reduces the risk of sustained eGFR, cardiovascular deaths and hospitalization for heart failure in adults with CKD


Lonza collaborates with AbTis to extend Bioconjugation capabilities
Biotech | November 30, 2022

Lonza collaborates with AbTis to extend Bioconjugation capabilities

Collaboration to implement AbTis’ AbClick platform into Lonza’s bioconjugation toolbox