Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 5

Results For "Investigational-New-Drug"

61 News Found

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


USFDA issues new clinical trial guidelines for cancer treatments
News | March 02, 2022

USFDA issues new clinical trial guidelines for cancer treatments

USFDA's industry recommendations and cancer Moonshot aim to improve lives of patients and their families


USFDA lifts clinical hold on submission of Covaxin
News | February 20, 2022

USFDA lifts clinical hold on submission of Covaxin

Covaxin is a whole-virion inactivated Covid-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades


Center for Breakthrough Medicines launches analytical testing
Biotech | February 17, 2022

Center for Breakthrough Medicines launches analytical testing

More than 2,500 submissions are currently under review in the Food and Drug Administration's (FDA) cell and gene therapy pipeline


Kato wins USFDA approval for studies in retinal disorder
Biotech | February 17, 2022

Kato wins USFDA approval for studies in retinal disorder

Resolv ER may remedy leading causes of blindness in adults


USFDA approves IND application for Allied’s cancer treatment
Biotech | January 24, 2022

USFDA approves IND application for Allied’s cancer treatment

APS03118 is a novel innovative drug developed by APS with global independent intellectual property rights for unlimited cancer types


Lannett receives USFDA safety review for biosimilar insulin glargine
Biotech | January 22, 2022

Lannett receives USFDA safety review for biosimilar insulin glargine

Go-ahead for pivotal clinical trial which is expected to commence by March


Palleon announces IND clearance for first-in-class cancer immunotherapy
Biotech | January 21, 2022

Palleon announces IND clearance for first-in-class cancer immunotherapy

Phase 1/2 trial of E-602 expected to open in Q1 2022 in patients with solid tumours