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Results For "submission"

300 News Found

AbbVie seeks FDA approval for Pivekimab Sunirine to treat rare, aggressive blood cancer
Drug Approval | October 01, 2025

AbbVie seeks FDA approval for Pivekimab Sunirine to treat rare, aggressive blood cancer

BPDCN is a challenging blood cancer with characteristics of both leukemia and lymphoma


AbbVie submits application to FDA for Tavapadon for treatment of Parkinson's disease
Drug Approval | September 29, 2025

AbbVie submits application to FDA for Tavapadon for treatment of Parkinson's disease

If approved, tavapadon will enhance AbbVie's leadership in Parkinson's disease by providing patients with a once daily oral treatment option


Pi Health to deliver clinical research services for  GSK’s Phase 2 oncology trial
News | September 26, 2025

Pi Health to deliver clinical research services for GSK’s Phase 2 oncology trial

Physician-led Pi Health has demonstrated capabilities to dramatically reduce clinical trial timelines and administrative burden, while increasing data quality


Dr. Reddy's receives positive CHMP opinion from EMA for denosumab 'AVT03'
News | September 24, 2025

Dr. Reddy's receives positive CHMP opinion from EMA for denosumab 'AVT03'

Prolia is a prescription medicine used to treat osteoporosis in women


Moderna delivers Canada’s first locally manufactured mRNA vaccines
News | September 23, 2025

Moderna delivers Canada’s first locally manufactured mRNA vaccines

All drug substance for Moderna’s authorized Spikevax (COVID-19 mRNA vaccine) targeting the SARS-CoV-2 LP.8.1 variant is produced at the company’s facility in Laval, Quebec


Rona submits IND for GalNAc-conjugated siRNA targeting obesity
Drug Approval | September 16, 2025

Rona submits IND for GalNAc-conjugated siRNA targeting obesity

RN3161 is engineered to reduce fat while preserving lean mass, setting it apart from current treatment options


Kytopen collaborates with BlueWhale Bio for cell therapy manufacturing
Biotech | September 12, 2025

Kytopen collaborates with BlueWhale Bio for cell therapy manufacturing

Both will develop a non-viral manufacturing workflow designed to eliminate key bottlenecks and accelerate the delivery of lifesaving engineered cell therapies to patients


AstraZeneca’s Baxdrostat proves effective in in Phase III trial for hard-to-control hypertension
Clinical Trials | September 05, 2025

AstraZeneca’s Baxdrostat proves effective in in Phase III trial for hard-to-control hypertension

The medicine was well tolerated, with no unexpected safety issue