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Results For "Investigational-New-Drug"

78 News Found

SCG Cell Therapy announces HSA clinical trial approval of TCR-T cell therapy for liver cancer
Biotech | May 09, 2022

SCG Cell Therapy announces HSA clinical trial approval of TCR-T cell therapy for liver cancer

SCG101 is an autologous T-cell receptor (TCR) T-cell therapy for liver cancer


USFDA approves Phase 3 Acute Respiratory Distress Syndrome (ARDS), trial
Biotech | April 22, 2022

USFDA approves Phase 3 Acute Respiratory Distress Syndrome (ARDS), trial

The Phase 3 trial will be conducted under the auspices of the first Regenerative Medicine Advanced Therapy (RMAT) designation approved by the USFDA for an EV therapeutic


Terran Biosciences announces licensing deal with Sanofi
Biotech | April 22, 2022

Terran Biosciences announces licensing deal with Sanofi

Terran to advance the development of two of Sanofi's Phase 3 CNS therapeutics


Henlius' Serplulimab granted Orphan-Drug Designation for Small Cell Lung Cancer
Biotech | April 08, 2022

Henlius' Serplulimab granted Orphan-Drug Designation for Small Cell Lung Cancer

The company plans to file its NDA in China and MAA in the EU in 2022, making Hansizhuang potentially to be the world's first PD-1 inhibitor for the first-line treatment of SCLC


USFDA clears IND application for an intranasal RSV vaccine
Biotech | March 29, 2022

USFDA clears IND application for an intranasal RSV vaccine

The companies are now preparing to initiate a Phase 1 trial to assess the safety and immunogenicity of BLB-201 in healthy volunteers


Insilico Medicine and EQRx to jointly advance AI-driven drug discovery
Biotech | March 24, 2022

Insilico Medicine and EQRx to jointly advance AI-driven drug discovery

The collaboration leverages Insilico's end-to-end AI-driven Pharma.AI platform to discover novel small molecule drug candidates for multiple targets, along with EQRx's innovative business model to accelerate drug development and patient access to novel medicines at affordable prices


Orgenics to conduct toxicology study on its intransal COVID-19 vaccine candidate
Biotech | March 23, 2022

Orgenics to conduct toxicology study on its intransal COVID-19 vaccine candidate

Data to establish the safety profile and human dose of vaccine candidate


Wockhardt’s novel antibiotic Phase 1 trial to be conducted by NIH, USA
Biotech | March 16, 2022

Wockhardt’s novel antibiotic Phase 1 trial to be conducted by NIH, USA

The USFDA has granted a qualified infectious disease product (QIDP) designation to WCK 6777, which signifies its ability to meet unmet medical needs and facilitates a faster approval process


Oragenics announces positive data on Covid-19 intranasal vaccine
Biotech | March 04, 2022

Oragenics announces positive data on Covid-19 intranasal vaccine

Intranasal immunization lowers the viral load below the limit of detection in lungs of hamsters


USFDA refuses to grant EUA to Covaxin for padeatric use
News | March 04, 2022

USFDA refuses to grant EUA to Covaxin for padeatric use

Covaxin is not approved in the USA for any age group