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Results For "submission"

300 News Found

Indegene launches NEXT Medical Writing Automation
News | July 12, 2025

Indegene launches NEXT Medical Writing Automation

To streamline complex medical writing workflows with GenAI


Novo Nordisk submits application to EMA for higher dose of Wegovy for obesity treatment
Clinical Trials | July 09, 2025

Novo Nordisk submits application to EMA for higher dose of Wegovy for obesity treatment

The submission is based on data from the STEP UP and STEP UP T2D clinical trials


Shukra Pharmaceuticals receives LoA from RMSCL
News | June 28, 2025

Shukra Pharmaceuticals receives LoA from RMSCL

The company has been awarded a contract for the supply of essential pharmaceutical formulations to government health institutions across Rajasthan


Philogen withdraws marketing authorization application for Nidlegy in EU
News | June 26, 2025

Philogen withdraws marketing authorization application for Nidlegy in EU

The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls


iNGENu CRO, Quantum BioPharma to launch Australian trial for chronic nociplastic pain in MCAS patients
Clinical Trials | June 04, 2025

iNGENu CRO, Quantum BioPharma to launch Australian trial for chronic nociplastic pain in MCAS patients

The trial targets MCAS/MCAD, an under-recognized, debilitating condition with an unknown cause and no cure


Pimicotinib demonstrates best-in-class potential with significant efficacy and clinically meaningful improvements in patients with tenosynovial giant cell tumor
News | May 29, 2025

Pimicotinib demonstrates best-in-class potential with significant efficacy and clinically meaningful improvements in patients with tenosynovial giant cell tumor

MANEUVER met all five key secondary endpoints, with statistically significant and clinically meaningful improvements in pain, stiffness, range of motion, physical function, and decrease in tumor volume


Granules India bags EcoVadis’ Gold Rating
Sustainability | May 08, 2025

Granules India bags EcoVadis’ Gold Rating

The company's first-ever corporate-level submission to EcoVadis builds on years of operational and environmental excellence


USFDA grants Priority Review for new indication of finerenone for patients with common heart failure
Drug Approval | March 20, 2025

USFDA grants Priority Review for new indication of finerenone for patients with common heart failure

Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure


RedHill Biopharma to submit FDA-approved Talicia for UK marketing authorisation
Drug Approval | March 19, 2025

RedHill Biopharma to submit FDA-approved Talicia for UK marketing authorisation

Talicia is also approved and launched in the UAE and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes