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Results For "U.S.-Food-and-Drug-Administration"

594 News Found

Medtronic announces first patient implants for bladder incontinence
Medical Device | March 25, 2022

Medtronic announces first patient implants for bladder incontinence

Titan 2 pivotal study to evaluate implantable tibial neuromodulation (TNM) device to help expand patient access to advanced therapy


Pfizer granted USFDA Breakthrough Therapy Designation for RSV vaccine candidate
Drug Approval | March 24, 2022

Pfizer granted USFDA Breakthrough Therapy Designation for RSV vaccine candidate

The FDA decision is primarily informed by the positive results of a proof-of-concept, Phase 2a study evaluating the safety, immunogenicity, and efficacy of a single dose of 120µg RSVpreF in a human viral challenge model in healthy adults 18 to 50 years of age


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


Merck’s Keytruda approved for fourth gynecologic cancer indication
Drug Approval | March 22, 2022

Merck’s Keytruda approved for fourth gynecologic cancer indication

The approval is based on new data from cohorts D and K of the KEYNOTE-158 trial


USFDA approves Perrigo’s Nasonex
Drug Approval | March 21, 2022

USFDA approves Perrigo’s Nasonex

Nasonex is a registered trademark of Organon and is used by Perrigo and its affiliates under license


Biological Dynamics study demonstrates detection of early-stage cancers
Biotech | March 21, 2022

Biological Dynamics study demonstrates detection of early-stage cancers

In a Nature Communications Medicine publication, the Verita proprietary platform detected 96 per cent of stage 1 pancreatic cancers and three-quarters of stage 1 ovarian cancers using isolated exosomes and AI-enabled protein marker analysis


USFDA approves Opdualag to treat metastatic melanoma
Drug Approval | March 19, 2022

USFDA approves Opdualag to treat metastatic melanoma

Opdualag is a first-in-class, fixed-dose dual immunotherapy combination treatment of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab


USFDA approves Marinus’ treatment for genetic disorder
Drug Approval | March 19, 2022

USFDA approves Marinus’ treatment for genetic disorder

First and only FDA-approved treatment for seizures associated with CDKL5 deficiency disorder (CDD) in patients two years of age and older


USFDA approves Rinvoq for ulcerative colitis
Drug Approval | March 17, 2022

USFDA approves Rinvoq for ulcerative colitis

First approved in 2019, Rinvoq is a JAK inhibitor approved for four indications across gastroenterology, dermatology and rheumatology


USFDA EUA for point-of-care Covid-19 rapid PCR test
Medical Device | March 17, 2022

USFDA EUA for point-of-care Covid-19 rapid PCR test

DASH enables non-laboratory personnel to insert a nasal swab specimen directly into our test cartridge and then load the cartridge into the DASH instrument, providing an accurate result in about 15 minutes