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Results For "submission"

300 News Found

Vertex announces advancements of Suzetrigine in acute and neuropathic pain
News | April 22, 2024

Vertex announces advancements of Suzetrigine in acute and neuropathic pain

Breakthrough Therapy designation for pain associated with DPN granted by FDA


GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA
Drug Approval | April 17, 2024

GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA

Submission based on results from pivotal phase III trial showing all primary endpoints met


AbbVie announces late-breaking data at AAN supporting efficacy of Atogepant for preventive treatment of migraine
Clinical Trials | April 17, 2024

AbbVie announces late-breaking data at AAN supporting efficacy of Atogepant for preventive treatment of migraine

Interim analysis of an ongoing 156-week extension study supports long-term safety, tolerability and efficacy of atogepant 60 mg to prevent chronic and episodic migraine


Pfizer announces positive Phase 3 trial of ADCETRIS regimen in patients with DLBCL
Clinical Trials | March 12, 2024

Pfizer announces positive Phase 3 trial of ADCETRIS regimen in patients with DLBCL

Pfizer to discuss regulatory submission with FDA, potentially leading to eighth indication for ADCETRIS


USFDA grants Orphan Drug Designation for iOnctura's first-in-class autotaxin cancer therapy
Biotech | March 12, 2024

USFDA grants Orphan Drug Designation for iOnctura's first-in-class autotaxin cancer therapy

It is the first autotaxin inhibitor to be investigated in cancer patients


Biomanufacturing and Bio-foundry will drive India’s future bioeconomy: Dr. Jitendra Singh
Biotech | March 07, 2024

Biomanufacturing and Bio-foundry will drive India’s future bioeconomy: Dr. Jitendra Singh

India has reached to nearly 6,000 bio-startups from 50 in the past 10 years


EMA validates MAAs for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in two types of cancer
Drug Approval | March 07, 2024

EMA validates MAAs for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in two types of cancer

The validations confirm the completion of the applications and commence the scientific review process


Orchid Pharma's 'Exblifep' receives USFDA approval
Drug Approval | February 24, 2024

Orchid Pharma's 'Exblifep' receives USFDA approval

Orchid is the first company from India, ever to have invented a product which has received a New Drug Approval (NDA) from USFDA


MIRA Pharmaceuticals announces collaboration with Pharmaseed
News | February 08, 2024

MIRA Pharmaceuticals announces collaboration with Pharmaseed

Studies will Investigate Antidepressant Properties of Ketamir to Position for Initial IND Application in 2024


Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours
Drug Approval | January 31, 2024

Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours

Submission to be reviewed under FDA real-time oncology review and Project Orbis