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Results For "clinical-trial"

805 News Found

US FDA grants Lantern Pharma additional Orphan Drug tag for LP-184
Biotech | August 31, 2021

US FDA grants Lantern Pharma additional Orphan Drug tag for LP-184

The drug is also intended for the treatment of glioblastoma multiforme


Sanofi’s Dupixent pivotal trial meets all primary and secondary endpoints for treatment of atopic dermatitis
Biotech | August 31, 2021

Sanofi’s Dupixent pivotal trial meets all primary and secondary endpoints for treatment of atopic dermatitis

Results reinforce the well-established safety profile of Dupixent - the first-ever biologic medicine for atopic dermatitis currently approved for patients as young 6 years old


Visby Medical receives FDA approval and CLIA waiver for PCR sexual health test
Drug Approval | August 30, 2021

Visby Medical receives FDA approval and CLIA waiver for PCR sexual health test

The Visby Medical sexual health click test is the first instrument-free PCR test for the detection of chlamydia, gonorrhoea and trichomonas, with results available within 30 minutes, during the patient visit


DCGI approves Enzene biosimilar Denosumab for Osteoporosis
Drug Approval | August 28, 2021

DCGI approves Enzene biosimilar Denosumab for Osteoporosis

This is Enzene Biosciences third biosimilar to be approved


Indoco’s AnaCipher receives UK-MHRA accreditation
Drug Approval | August 27, 2021

Indoco’s AnaCipher receives UK-MHRA accreditation

The clinical research organisation located in Hyderabad is a USFDA inspected facility


Johnson & Johnson booster dose indicate impressive results
Drug Approval | August 26, 2021

Johnson & Johnson booster dose indicate impressive results

New interim data from these studies demonstrate that a booster dose of the Johnson & Johnson Covid-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after the primary single-dose vaccination.


Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose
Drug Approval | August 26, 2021

Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose

The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks


Adjuvance announce clinical results of its next-gen saponin adjuvant
Biotech | August 26, 2021

Adjuvance announce clinical results of its next-gen saponin adjuvant

First results demonstrate favourable tolerability of TQL-1055 at all dose levels


Lonza to establish manufacturing facility in Guangzhou, China
News | August 25, 2021

Lonza to establish manufacturing facility in Guangzhou, China

The investment will establish drug product manufacturing capacity for clinical trial and commercial supply in China and offer customers combined drug substance and drug product manufacturing services


US FDA approves Medtronic’s TAVR System
Drug Approval | August 25, 2021

US FDA approves Medtronic’s TAVR System

The Evolut FX TAVR system is used for treatment of symptomatic severe aortic stenosis and it has features that enhance ease-of-use and predictable valve deployment