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Home / FDA - Page 25

FDA

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 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

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

Mylan ramped up U.S. manufacturing of hydroxychloroquine sulfate tablets to meet potential COVID-19 patient needs
Biotechnology | COVID-19 | FDA | Infectious Disease | Therapeutics

Mylan ramped up U.S. manufacturing of hydroxychloroquine sulfate tablets to meet potential COVID-19 patient needs

On Mar. 19, 2020, Mylan announced it had restarted production of hydroxychloroquine sulfate tablets at its West Virginia…

Read More Mylan ramped up U.S. manufacturing of hydroxychloroquine sulfate tablets to meet potential COVID-19 patient needsContinue

Abbott received FDA Emergency Use Authorization and launches test to detect novel Coronavirus
COVID-19 | FDA | Life Science History

Abbott received FDA Emergency Use Authorization and launches test to detect novel Coronavirus

On Mar. 19, 2020, Abbott announced the FDA has issued Emergency Use Authorization (EUA) for the company’s molecular…

Read More Abbott received FDA Emergency Use Authorization and launches test to detect novel CoronavirusContinue

Roche initiated phase III clinical trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 pneumonia
Biotechnology | COVID-19 | FDA | Infectious Disease | Therapeutics

Roche initiated phase III clinical trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 pneumonia

On Mar. 19, 2020, Roche announced it was working with the U.S. Food & Drug Administration (FDA) to…

Read More Roche initiated phase III clinical trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 pneumoniaContinue

FDA approved Epclusa (Sofosbuvir/Velpatasvir) for children with Chronic Hepatitis C infection
Biotechnology | FDA | Therapeutics

FDA approved Epclusa (Sofosbuvir/Velpatasvir) for children with Chronic Hepatitis C infection

On Mar. 19, 2020, Gilead Sciences announced the U.S. Food and Drug Administration (FDA) had approved a supplemental…

Read More FDA approved Epclusa (Sofosbuvir/Velpatasvir) for children with Chronic Hepatitis C infectionContinue

Abbott received FDA Emergency Use Authorization and launched test to detect novel Coronavirus
COVID-19 | FDA | Life Science History

Abbott received FDA Emergency Use Authorization and launched test to detect novel Coronavirus

On Mar. 18, 2020, Abbott announced that the FDA had issued Emergency Use Authorization (EUA) for the company’s…

Read More Abbott received FDA Emergency Use Authorization and launched test to detect novel CoronavirusContinue

Mateon to develop its OT-101, a phase 3 clinical drug candidate against COVID-19
Biotechnology | COVID-19 | FDA | Therapeutics

Mateon to develop its OT-101, a phase 3 clinical drug candidate against COVID-19

On Mar. 18, 2020, Mateon Therapeutics reported significant progress in deploying its phase 3 clinical asset, OT-101, against…

Read More Mateon to develop its OT-101, a phase 3 clinical drug candidate against COVID-19Continue

Eli Lilly and Indiana State Department of Health partnered to accelerate COVID-19 testing using Lilly Research Laboratories
COVID-19 | FDA | Life Science History

Eli Lilly and Indiana State Department of Health partnered to accelerate COVID-19 testing using Lilly Research Laboratories

On Mar. 18, 2020, Eli Lilly announced its scientists were partnering with the Indiana State Department of Health…

Read More Eli Lilly and Indiana State Department of Health partnered to accelerate COVID-19 testing using Lilly Research LaboratoriesContinue

Quidel received Emergency Use Authorization for molecular COVID-19 diagnostic assay
Biotechnology | COVID-19 | Diagnostics | FDA

Quidel received Emergency Use Authorization for molecular COVID-19 diagnostic assay

On Mar. 17, 2020, Quidel Corp. announced it had received Emergency Use Authorization (EUA) from the U.S. Food…

Read More Quidel received Emergency Use Authorization for molecular COVID-19 diagnostic assayContinue

Latest FDA guidance allows distribution of SARS-CoV-2 serology tests for diagnostic use
COVID-19 | FDA | Life Science History

Latest FDA guidance allows distribution of SARS-CoV-2 serology tests for diagnostic use

On Mar. 17, 2020, BioMedomics announced it will be able to distribute their COVID-19 IgM-IgG Antibody Rapid Test…

Read More Latest FDA guidance allows distribution of SARS-CoV-2 serology tests for diagnostic useContinue

Todos Medical announced Coronavirus Nucleic Acid Buccal Testing Kit distribution agreement with 3D BioMed
Biotechnology | COVID-19 | Diagnostics | FDA | Medical Device

Todos Medical announced Coronavirus Nucleic Acid Buccal Testing Kit distribution agreement with 3D BioMed

On Mar. 17, 2020, Todos Medical announced a non-exclusive distribution agreement with 3D Biomedicine Science & Technology, a…

Read More Todos Medical announced Coronavirus Nucleic Acid Buccal Testing Kit distribution agreement with 3D BioMedContinue

Aimmune announced first U.S. patients treated with PALFORZIA, the first treatment for peanut allergy
Biotechnology | FDA | Therapeutics

Aimmune announced first U.S. patients treated with PALFORZIA, the first treatment for peanut allergy

On Mar. 16, 2020, Aimmune Therapeutics announced that the first patients in the U.S. were being treated with…

Read More Aimmune announced first U.S. patients treated with PALFORZIA, the first treatment for peanut allergyContinue

Hologic’s molecular test for the novel Coronavirus, SARS-CoV-2, receives FDA Emergency Use Authorization
Biotechnology | COVID-19 | Diagnostics | FDA

Hologic’s molecular test for the novel Coronavirus, SARS-CoV-2, receives FDA Emergency Use Authorization

On Mar. 16, 2020, Hologic announced the U.S. Food and Drug Administration (FDA) had granted Emergency Use Authorization…

Read More Hologic’s molecular test for the novel Coronavirus, SARS-CoV-2, receives FDA Emergency Use AuthorizationContinue

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

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

On Mar. 16, 2020, BD (Becton, Dickinson and Company) announced the companies had submitted Emergency Use Authorization requests…

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

Roche announced FDA Emergency Use Authorization and availablabilityof cobas SARS-CoV-2 detection test
COVID-19 | FDA | Life Science History

Roche announced FDA Emergency Use Authorization and availablabilityof cobas SARS-CoV-2 detection test

On Mar. 13, 2020, Roche announced the FDA has issued an Emergency Use Authorization for the cobasᆴ SARS-CoV-2…

Read More Roche announced FDA Emergency Use Authorization and availablabilityof cobas SARS-CoV-2 detection testContinue

FDA issued Emergency Use Authorization to Thermo Fisher Scientific for diagnostic test for COVID-19
COVID-19 | FDA | Life Science History

FDA issued Emergency Use Authorization to Thermo Fisher Scientific for diagnostic test for COVID-19

On Mar. 13, 2020, Thermo Fisher Scientific announced the FDA has issued an emergency use authorization (EUA) for…

Read More FDA issued Emergency Use Authorization to Thermo Fisher Scientific for diagnostic test for COVID-19Continue

The FDA approved the first treatment for group of progressive interstitial lung diseases
FDA | Life Science History

The FDA approved the first treatment for group of progressive interstitial lung diseases

On Mar. 9, 2020, the FDA approved Boehringer Ingelheim’s Ofev (nintedanib) oral capsules to treat patients with chronic…

Read More The FDA approved the first treatment for group of progressive interstitial lung diseasesContinue

The FDA approved new treatment for adults with Cushing’s disease
Biotechnology | Disease | FDA | Therapeutics

The FDA approved new treatment for adults with Cushing’s disease

On Mar. 6, 2020, the FDA approved Isturisa (osilodrostat) oral tablets for adults with Cushing’s disease who either…

Read More The FDA approved new treatment for adults with Cushing’s diseaseContinue

University of Washington Medicine deployed new test for coronavirus
FDA | Life Science History

University of Washington Medicine deployed new test for coronavirus

On Mar. 4, 2020, the UW Medicine Clinical Virology Lab announced it had received U.S. Food and Drug…

Read More University of Washington Medicine deployed new test for coronavirusContinue

Mateon updated Rapid Antiviral Response Program Initially targeting COVID-19
Biotechnology | COVID-19 | FDA | Therapeutics

Mateon updated Rapid Antiviral Response Program Initially targeting COVID-19

On Mar. 2, 2020, Mateon Therapeutics reported the company had been evaluating its therapeutic and AI platforms to…

Read More Mateon updated Rapid Antiviral Response Program Initially targeting COVID-19Continue

University of Washington Medicine received FDA permission to conduct coronavirus tests
Biotechnology | COVID-19 | Diagnostics | FDA | Non-Profit Research

University of Washington Medicine received FDA permission to conduct coronavirus tests

On Feb. 29, 2020, the University of Washington (UW) Medicine Clinical Virology Lab announced it had received U.S….

Read More University of Washington Medicine received FDA permission to conduct coronavirus testsContinue

The FDA approved a generic version of Daraprim for the treatment of toxoplasmosis
FDA | Life Science History

The FDA approved a generic version of Daraprim for the treatment of toxoplasmosis

On Feb. 28, 2020, the FDA approved an application for the first generic of Daraprim (pyrimethamine) tablets for…

Read More The FDA approved a generic version of Daraprim for the treatment of toxoplasmosisContinue

Innovation Pharma submited Material Transfer Agreement to study defensin mimetic Brilacidin for Coronavirus
FDA | Life Science History

Innovation Pharma submited Material Transfer Agreement to study defensin mimetic Brilacidin for Coronavirus

On Feb. 24, 2020, Innovation Pharmaannounced the Company submitted a Material Transfer Agreement (MTA) with a leading U.S.-based…

Read More Innovation Pharma submited Material Transfer Agreement to study defensin mimetic Brilacidin for CoronavirusContinue

Federal Judge ruled missing clinical trial data must be made public
FDA | NIH | U.S. Congress

Federal Judge ruled missing clinical trial data must be made public

On Feb. 22, 2020, a federal judge from the Southern District of New York ruled drug companies, device…

Read More Federal Judge ruled missing clinical trial data must be made publicContinue

The FDA approved non-statin drug to treat high cholesterol
Biotechnology | FDA | Therapeutics

The FDA approved non-statin drug to treat high cholesterol

On Feb. 21, 2020, the U.S. Food and Drug Administration (FDA) approved NEXLETOL (bempedoic acid) tablet, an oral,…

Read More The FDA approved non-statin drug to treat high cholesterolContinue

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