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Home / FDA - Page 23

FDA

Cumberland Pharma expanded availability of Vaprisol to treat Hyponatremia for critical care COVID-19 patients
COVID-19 | FDA | Therapeutics

Cumberland Pharma expanded availability of Vaprisol to treat Hyponatremia for critical care COVID-19 patients

On Apr. 7, 2020, Cumberland Pharma announced an initiative to increase availability of Vaprisol (conivaptan hydrochloride) injection for…

Read More Cumberland Pharma expanded availability of Vaprisol to treat Hyponatremia for critical care COVID-19 patientsContinue

FDA cleared Mesoblast IND for remestemcel use in COVID-19 ARDS patients
COVID-19 | FDA | Therapeutics

FDA cleared Mesoblast IND for remestemcel use in COVID-19 ARDS patients

On Apr. 6, 2020, Mesoblast announced it had received clearance from the U.S. Food and Drug Administration (FDA)…

Read More FDA cleared Mesoblast IND for remestemcel use in COVID-19 ARDS patientsContinue

INOVIO initiated phase 1 clinical trial of its COVID-19 vaccine
COVID-19 | FDA | Infectious Disease | Vaccine

INOVIO initiated phase 1 clinical trial of its COVID-19 vaccine

On Apr. 6, 2020, Inovio Pharma announced the U.S. Food and Drug Administration (FDA) had accepted the company’s…

Read More INOVIO initiated phase 1 clinical trial of its COVID-19 vaccineContinue

OraSure Technologies received BARDA contract for Rapid Oral Fluid Pan-SARS-Coronavirus in-home self-test
Biotechnology | Diagnostics | FDA | Infectious Disease

OraSure Technologies received BARDA contract for Rapid Oral Fluid Pan-SARS-Coronavirus in-home self-test

On Apr. 6, 2020, OraSure Technologies announced it had been awarded a $710,310 contract from the Biomedical Advanced…

Read More OraSure Technologies received BARDA contract for Rapid Oral Fluid Pan-SARS-Coronavirus in-home self-testContinue

Luminex received FDA Emergency Use Authorization for ARIES SARS-CoV-2 assay to detect virus responsible for COVID-19 disease
Biotechnology | COVID-19 | FDA | Medical Device

Luminex received FDA Emergency Use Authorization for ARIES SARS-CoV-2 assay to detect virus responsible for COVID-19 disease

On Apr. 6, 2020, Luminex announced announced that the FDA has issued an Emergency Use Authorization for its…

Read More Luminex received FDA Emergency Use Authorization for ARIES SARS-CoV-2 assay to detect virus responsible for COVID-19 diseaseContinue

Mayo Clinic named national site for Convalescent Plasma Expanded Access Program
Biotechnology | COVID-19 | FDA | Infectious Disease | Therapeutics

Mayo Clinic named national site for Convalescent Plasma Expanded Access Program

On Apr. 3, 2020, the FDA announced that the Mayo Clinic Mayo Clinic will be the lead institution…

Read More Mayo Clinic named national site for Convalescent Plasma Expanded Access ProgramContinue

BD, BioGX announced FDA Emergency Use Authorization for new COVID-19 diagnostic for use in U.S.
COVID-19 | Diagnostics | FDA

BD, BioGX announced FDA Emergency Use Authorization for new COVID-19 diagnostic for use in U.S.

On Apr. 3, 2020, BD (Becton, Dickinson) and BioGX announced that the U.S. Food and Drug Administration (FDA)…

Read More BD, BioGX announced FDA Emergency Use Authorization for new COVID-19 diagnostic for use in U.S.Continue

XBiotech and BioBridge Global collaborate on FDA program to develop potential COVID-19 antibody-based treatment
COVID-19 | FDA | Life Science History

XBiotech and BioBridge Global collaborate on FDA program to develop potential COVID-19 antibody-based treatment

On Apr. 3, 2020, XBiotech and BioBridge Global announced a collaboration to participate in a FDA investigational program…

Read More XBiotech and BioBridge Global collaborate on FDA program to develop potential COVID-19 antibody-based treatmentContinue

FDA approved Emergency IND Use of Humanigen’s lenzilumab for compassionate use in COVID-19 patients
COVID-19 | Diagnostics | FDA

FDA approved Emergency IND Use of Humanigen’s lenzilumab for compassionate use in COVID-19 patients

On Apr. 2, 2020, Humanigen announced that the company had submitted an initial protocol synopsis to the U.S….

Read More FDA approved Emergency IND Use of Humanigen’s lenzilumab for compassionate use in COVID-19 patientsContinue

Incyte initiated phase 3 clinical trial of Ruxolitinib (Jakafi) as treatment for patients with COVID-19  cytokine storm
Biotechnology | COVID-19 | FDA | Therapeutics

Incyte initiated phase 3 clinical trial of Ruxolitinib (Jakafi) as treatment for patients with COVID-19 cytokine storm

On Apr. 2, 2020, Incyte announced it was working with the U.S. Food and Drug Administration (FDA) to…

Read More Incyte initiated phase 3 clinical trial of Ruxolitinib (Jakafi) as treatment for patients with COVID-19 cytokine stormContinue

Luminex received BARDA contract to support development of second, rapid SARS-CoV-2 test
Biotechnology | COVID-19 | Diagnostics | FDA | Infectious Disease

Luminex received BARDA contract to support development of second, rapid SARS-CoV-2 test

On Mar. 31, 2020, Luminex announced it had received $642,450 in funding from the Biomedical Advanced Research and…

Read More Luminex received BARDA contract to support development of second, rapid SARS-CoV-2 testContinue

Medtronic shared ventilation design specifications to accelerate efforts to increase global ventilator production
COVID-19 | FDA | Medical Device | Therapeutics

Medtronic shared ventilation design specifications to accelerate efforts to increase global ventilator production

On Mar. 30, 2020 Medtronic announced it was publicly sharing the design specifications for the Puritan Bennett 560…

Read More Medtronic shared ventilation design specifications to accelerate efforts to increase global ventilator productionContinue

Humanigen partnered with CTI for planned phase III study for lenzilumab for coronavirus treatment
COVID-19 | FDA | Life Science History

Humanigen partnered with CTI for planned phase III study for lenzilumab for coronavirus treatment

On Mar. 30, 2020, Humanigen announced that the company had submitted an initial protocol synopsis to the FDA…

Read More Humanigen partnered with CTI for planned phase III study for lenzilumab for coronavirus treatmentContinue

Bellerophon Therapeutics announced first patient treated with INOpulse inhaled nitric oxide therapy for COVID-19
COVID-19 | FDA | Medical Device | Non-Profit Research | Therapeutics

Bellerophon Therapeutics announced first patient treated with INOpulse inhaled nitric oxide therapy for COVID-19

On Mar. 30, 2020, Bellerophon Therapeutics announced that expanded access treatment with the INOpulse inhaled nitric oxide system…

Read More Bellerophon Therapeutics announced first patient treated with INOpulse inhaled nitric oxide therapy for COVID-19Continue

FDA issued EUA to allow hydroxychloroquine sulfate and chloroquine phosphate products from Strategic National Stockpile to be distributed
Biotechnology | COVID-19 | FDA | Therapeutics

FDA issued EUA to allow hydroxychloroquine sulfate and chloroquine phosphate products from Strategic National Stockpile to be distributed

On Mar. 28, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to…

Read More FDA issued EUA to allow hydroxychloroquine sulfate and chloroquine phosphate products from Strategic National Stockpile to be distributedContinue

Military scientists, engineers develop ventilator prototype
FDA | Life Science History

Military scientists, engineers develop ventilator prototype

On Mar. 27, 2020, scientists and engineers at Naval Surface Warfare Center Panama City Division announced development of…

Read More Military scientists, engineers develop ventilator prototypeContinue

Abbott launched molecular point-of-care test to detect novel Coronavirus in as Little as five minutes
COVID-19 | FDA | Life Science History

Abbott launched molecular point-of-care test to detect novel Coronavirus in as Little as five minutes

On Mar. 27, 2020, Abbott announced the FDA has issued Emergency Use Authorization (EUA) for the fastest available…

Read More Abbott launched molecular point-of-care test to detect novel Coronavirus in as Little as five minutesContinue

Abbott launched molecular point-of-care test to detect novel Coronavirus in as little as five minutes
COVID-19 | FDA | Life Science History

Abbott launched molecular point-of-care test to detect novel Coronavirus in as little as five minutes

On Mar. 27, 2020, Abbott announced that the FDA had issued Emergency Use Authorization (EUA) for the fastest…

Read More Abbott launched molecular point-of-care test to detect novel Coronavirus in as little as five minutesContinue

CIRM approved $5 Million in emergency funding for COVID-19 research
Biotechnology | COVID-19 | Diagnostics | FDA

CIRM approved $5 Million in emergency funding for COVID-19 research

On Mar. 27, 2020, in response to the crisis caused by the COVID-19 virus in California and around…

Read More CIRM approved $5 Million in emergency funding for COVID-19 researchContinue

Humanigen submitted phase III protocol synopsis to FDA for lenzilumab for Coronavirus treatment
Biotechnology | COVID-19 | Diagnostics | FDA | Life Science History | Therapeutics

Humanigen submitted phase III protocol synopsis to FDA for lenzilumab for Coronavirus treatment

On Mar. 27, 2020, Humanigen announced that the company had submitted an initial protocol synopsis to U.S. Food…

Read More Humanigen submitted phase III protocol synopsis to FDA for lenzilumab for Coronavirus treatmentContinue

Luminex receives FDA Emergency Use Authorization for NxTAG CoV Extended Panel to detect SARS-CoV-2 Virus
COVID-19 | Diagnostics | FDA | Medical Device

Luminex receives FDA Emergency Use Authorization for NxTAG CoV Extended Panel to detect SARS-CoV-2 Virus

On Mar. 27, 2020, Luminex announced the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization…

Read More Luminex receives FDA Emergency Use Authorization for NxTAG CoV Extended Panel to detect SARS-CoV-2 VirusContinue

FDA supports transparency and collaboration in drug approval process as clinical data summary pilot concluded
FDA | Life Science History

FDA supports transparency and collaboration in drug approval process as clinical data summary pilot concluded

On Mar. 26, 2020, the FDA reported that it had become increasingly clear that the FDA needed to…

Read More FDA supports transparency and collaboration in drug approval process as clinical data summary pilot concludedContinue

T2 Biosystems announced worldwide licensing agreement of COVID-19, novel Coronavirus assay
COVID-19 | FDA | Life Science History

T2 Biosystems announced worldwide licensing agreement of COVID-19, novel Coronavirus assay

On Mar. 24, 2020, T2 Biosystems announced it has entered into a worldwide licensing agreement for a rapid…

Read More T2 Biosystems announced worldwide licensing agreement of COVID-19, novel Coronavirus assayContinue

FDA provided Emergency Use Authorization to PerkinElmer for COVID-19 testing
COVID-19 | Diagnostics | FDA

FDA provided Emergency Use Authorization to PerkinElmer for COVID-19 testing

On Mar. 24, 2020, PerkinElmer announced the U.S. Food and Drug Administration (FDA) had provided Emergency Use Authorization…

Read More FDA provided Emergency Use Authorization to PerkinElmer for COVID-19 testingContinue

bioMerieux received FDA Emergency Use Authorization for BIOFIRE COVID-19 test
Biotechnology | COVID-19 | Diagnostics | FDA

bioMerieux received FDA Emergency Use Authorization for BIOFIRE COVID-19 test

On Mar. 24, 2020, bioMerieux announced that BioFire Diagnostics, its subsidiary specialized in syndromic infectious disease testing, had…

Read More bioMerieux received FDA Emergency Use Authorization for BIOFIRE COVID-19 testContinue

Mesa Biotech received Emergency Use Authorization from FDA for 30 minute point ofcCare molecular COVID-19 test
COVID-19 | FDA | Life Science History

Mesa Biotech received Emergency Use Authorization from FDA for 30 minute point ofcCare molecular COVID-19 test

On Mar. 24, 2020, Mesa Biotech announced it had received Emergency Use Authorization (EUA) from the FDA for…

Read More Mesa Biotech received Emergency Use Authorization from FDA for 30 minute point ofcCare molecular COVID-19 testContinue

Windtree announced clinical study of lung injury treatment in COVID-19 patients with its KL4 surfactant therapy
COVID-19 | FDA | Life Science History

Windtree announced clinical study of lung injury treatment in COVID-19 patients with its KL4 surfactant therapy

On Mar. 24, 2020, Windtree Therapeutics announced it will study its proprietary KL4 surfactant to potentially mitigate the…

Read More Windtree announced clinical study of lung injury treatment in COVID-19 patients with its KL4 surfactant therapyContinue

FDA Issues first Emergency Use Authorization for Point of Care Diagnostic
COVID-19 | FDA | Life Science History

FDA Issues first Emergency Use Authorization for Point of Care Diagnostic

On Mar. 21, 2020, the FDA issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for…

Read More FDA Issues first Emergency Use Authorization for Point of Care DiagnosticContinue

FDA allowed expanded use of devices to monitor patients’ vital signs remotely
Diagnostics | FDA | Medical Device

FDA allowed expanded use of devices to monitor patients’ vital signs remotely

On Mar. 20, 2020, the U.S. Food and Drug Administration (FDA) issued a new policy that allowed manufacturers…

Read More FDA allowed expanded use of devices to monitor patients’ vital signs remotelyContinue

FDA granted Bellerophon emergency expanded access for INOpulse  for treatment of COVID-19 virus
COVID-19 | FDA | Medical Device | Therapeutics

FDA granted Bellerophon emergency expanded access for INOpulse for treatment of COVID-19 virus

On Mar. 20, 2020, Bellerophon Therapeutics announced the U.S. Food and Drug Administration (FDA) had granted emergency expanded…

Read More FDA granted Bellerophon emergency expanded access for INOpulse for treatment of COVID-19 virusContinue

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