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Home / FDA - Page 18

FDA

Medigen Vaccines collaborated with Dynavax to develop novel adjuvanted COVID-19 vaccine candidate
Biotechnology | COVID-19 | FDA | Medicine | Therapeutics | Vaccine

Medigen Vaccines collaborated with Dynavax to develop novel adjuvanted COVID-19 vaccine candidate

On Jul. 23, 2020, Dynavax Technologies and Medigen Vaccine Biologics (MVC) announced a collaboration to develop an adjuvanted…

Read More Medigen Vaccines collaborated with Dynavax to develop novel adjuvanted COVID-19 vaccine candidateContinue

Findings from real-world data study reveal higher risk of hospitalization and death among cancer patients with COVID-19
COVID-19 | FDA | Life Science History

Findings from real-world data study reveal higher risk of hospitalization and death among cancer patients with COVID-19

On Jul. 22, 2020, the FDA announced the data analyzed in collaboration with Syapse revealed a stark reality…

Read More Findings from real-world data study reveal higher risk of hospitalization and death among cancer patients with COVID-19Continue

BD received FDA approval for HPV test with extended genotyping capabilities
Biotechnology | Diagnostics | FDA

BD received FDA approval for HPV test with extended genotyping capabilities

On Jul. 22, 2020, BD (Becton, Dickinson) announced that it had received approval for a pre-market approval (PMA)…

Read More BD received FDA approval for HPV test with extended genotyping capabilitiesContinue

Pfizer and BioNTech announced agreement with US government for up to 600 million doses of mRNA-based vaccine candidate against SARS-CoV-2
COVID-19 | FDA | Life Science History

Pfizer and BioNTech announced agreement with US government for up to 600 million doses of mRNA-based vaccine candidate against SARS-CoV-2

On Jul. 22, 2020, Pfizer and BioNTech announced execution of an agreement with the U.S. Department of Health…

Read More Pfizer and BioNTech announced agreement with US government for up to 600 million doses of mRNA-based vaccine candidate against SARS-CoV-2Continue

PerkinElmer released new dried blood spot based COVID-19 serology test
FDA | Life Science History

PerkinElmer released new dried blood spot based COVID-19 serology test

On Jul. 21, 2020, PerkinElmer announced the launch of a dry blood spot (DBS) based test for SARS-CoV-2…

Read More PerkinElmer released new dried blood spot based COVID-19 serology testContinue

Luminex received FDA Emergency Use Authorization for COVID-19 antibody test
COVID-19 | FDA | Life Science History

Luminex received FDA Emergency Use Authorization for COVID-19 antibody test

On Jul. 20, 2020, Luminex announced the FDA had issued an Emergency Use Authorization for the company’s xMAPᆴ…

Read More Luminex received FDA Emergency Use Authorization for COVID-19 antibody testContinue

The FDA FDA Issued first Emergency Authorization for sample pooling in diagnostic testing
FDA | Life Science History

The FDA FDA Issued first Emergency Authorization for sample pooling in diagnostic testing

On Jul. 18, 2020, the FDA reissued an emergency use authorization (EUA) to Quest Diagnostics to authorize its…

Read More The FDA FDA Issued first Emergency Authorization for sample pooling in diagnostic testingContinue

Heron Therapeutics announced initiation of phase 2 clinical study of CINVANTIᆴ for treatment of COVID-19
COVID-19 | FDA | Life Science History

Heron Therapeutics announced initiation of phase 2 clinical study of CINVANTIᆴ for treatment of COVID-19

On Jul. 16, 2020, Heron Therapeutics announced initiation of the GUARDS-1 Study, a Phase 2 clinical study evaluating…

Read More Heron Therapeutics announced initiation of phase 2 clinical study of CINVANTIᆴ for treatment of COVID-19Continue

Dynavax announced first participants dosed in phase 1 clinical evaluating Medicagoメs COVID-19 vaccine candidate
COVID-19 | FDA | Life Science History

Dynavax announced first participants dosed in phase 1 clinical evaluating Medicagoメs COVID-19 vaccine candidate

On Jul. 14, 2020, Dynavax Technologies announced that the first participants have been dosed in the Phase 1…

Read More Dynavax announced first participants dosed in phase 1 clinical evaluating Medicagoメs COVID-19 vaccine candidateContinue

Bellerophon Therapeutics announced first patient treated in phase 3 clinical study of INOpulseᆴ inhaled nitric oxide therapy for COVID-19
COVID-19 | FDA | Life Science History

Bellerophon Therapeutics announced first patient treated in phase 3 clinical study of INOpulseᆴ inhaled nitric oxide therapy for COVID-19

On Jul. 13, 2020, Bellerophon Therapeutics announced that the first patient has initiated treatment in the Companyメs Phase…

Read More Bellerophon Therapeutics announced first patient treated in phase 3 clinical study of INOpulseᆴ inhaled nitric oxide therapy for COVID-19Continue

Pfizer and BioNTech granted FDA Fast Track Designation for two investigational mRNA-based vaccine candidates against SARS-CoV-2
COVID-19 | FDA | Life Science History

Pfizer and BioNTech granted FDA Fast Track Designation for two investigational mRNA-based vaccine candidates against SARS-CoV-2

On Jul. 13, 2020, Pfizer and BioNTech announced that two of the companiesメ four investigational vaccine candidates from…

Read More Pfizer and BioNTech granted FDA Fast Track Designation for two investigational mRNA-based vaccine candidates against SARS-CoV-2Continue

Mylan and Fujifilm Kyowa Kirin Biologics announced FDA approval of Hulioᆴ (adalimumab-fkjp)
FDA | Life Science History

Mylan and Fujifilm Kyowa Kirin Biologics announced FDA approval of Hulioᆴ (adalimumab-fkjp)

On Jul. 9, 2020, Mylan and Fujifilm Kyowa Kirin Biologics announced the FDA had approved Hulioᆴ (adalimumab-fkjp), a…

Read More Mylan and Fujifilm Kyowa Kirin Biologics announced FDA approval of Hulioᆴ (adalimumab-fkjp)Continue

The FDA reported false positive results with BD SARS-CoV-2 reagents for the BD Max System
FDA | Life Science History

The FDA reported false positive results with BD SARS-CoV-2 reagents for the BD Max System

On Jul. 7, 2020, the FDA alerted clinical laboratory staff and health care providers of an increased risk…

Read More The FDA reported false positive results with BD SARS-CoV-2 reagents for the BD Max SystemContinue

The FDA reported false positive results with BD SARS-CoV-2 reagents for the BD Max System
FDA | Life Science History

The FDA reported false positive results with BD SARS-CoV-2 reagents for the BD Max System

On Jul. 7, 2020, the FDA alerted clinical laboratory staff and health care providers of an increased risk…

Read More The FDA reported false positive results with BD SARS-CoV-2 reagents for the BD Max SystemContinue

LabCorp lanuched first digital COVID-19 service that improves the doctor and patient experience
COVID-19 | FDA | Life Science History

LabCorp lanuched first digital COVID-19 service that improves the doctor and patient experience

On Jul. 7, 2020, LabCorpᆴ launched the LabCorp At Home COVID-19 Test Collection Service, the first seamless digital…

Read More LabCorp lanuched first digital COVID-19 service that improves the doctor and patient experienceContinue

Corvus Pharmaceuticals initiated clinical trial of novel immunotherapy for patients with COVID-19
COVID-19 | FDA | Pharmaceutical | Therapeutics

Corvus Pharmaceuticals initiated clinical trial of novel immunotherapy for patients with COVID-19

On Jul. 7, 2020, Corvus Pharmaceuticals announced that it has initiated a Phase 1 study to investigate a…

Read More Corvus Pharmaceuticals initiated clinical trial of novel immunotherapy for patients with COVID-19Continue

The FDA issued an emergency use authorization for the third diagnostic test for detection and differentiation of the viruses that cause flu and COVID-19
COVID-19 | FDA | Influenza | Life Science History

The FDA issued an emergency use authorization for the third diagnostic test for detection and differentiation of the viruses that cause flu and COVID-19

On Jul. 6, 2020, the FDA issued an emergency use authorization (EUA) for the third diagnostic test for…

Read More The FDA issued an emergency use authorization for the third diagnostic test for detection and differentiation of the viruses that cause flu and COVID-19Continue

The FDA approved Qwo (collagenase clostridium histolyticum-aaes), the first injectable treatment for cellulite
Biotechnology | FDA

The FDA approved Qwo (collagenase clostridium histolyticum-aaes), the first injectable treatment for cellulite

On Jul. 6, 2020, Endo International announced that it received FDA approval of Qwo (collagenase clostridium histolyticum-aaes) for…

Read More The FDA approved Qwo (collagenase clostridium histolyticum-aaes), the first injectable treatment for celluliteContinue

ADMA Biologics opened its newest ADMA BioCenters plasma collection facility
FDA | Life Science History

ADMA Biologics opened its newest ADMA BioCenters plasma collection facility

On Jul. 6, 2020, ADMA Biologics announced the commencement of operations and initiation of collections at its newest…

Read More ADMA Biologics opened its newest ADMA BioCenters plasma collection facilityContinue

BD launched portable, rapid point-of-care antigen test to detect SARS-CoV-2 in 15 minutes, expanding access to COVID-19 testing
COVID-19 | Diagnostics | FDA

BD launched portable, rapid point-of-care antigen test to detect SARS-CoV-2 in 15 minutes, expanding access to COVID-19 testing

On Jul. 6, 2020, BD (Becton, Dickinson) announced the U.S. Food and Drug Administration (FDA) had granted Emergency…

Read More BD launched portable, rapid point-of-care antigen test to detect SARS-CoV-2 in 15 minutes, expanding access to COVID-19 testingContinue

The FDA authorized additional COVID-19 combination diagnostic test ahead of flu season
COVID-19 | FDA | Influenza

The FDA authorized additional COVID-19 combination diagnostic test ahead of flu season

On Jul. 2, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for…

Read More The FDA authorized additional COVID-19 combination diagnostic test ahead of flu seasonContinue

The FDA approved new HIV treatment for patients with limited treatment options
Biotechnology | FDA | HIV | Therapeutics

The FDA approved new HIV treatment for patients with limited treatment options

On Jul. 2, 2020, the U.S. Food and Drug Administration (FDA) approved Rukobia (fostemsavir), a new type of…

Read More The FDA approved new HIV treatment for patients with limited treatment optionsContinue

FDA issued Emergency Use Authorization for Philips’ acute care patient monitoring solutions for hospitals
COVID-19 | Diagnostics | FDA | Medical Device

FDA issued Emergency Use Authorization for Philips’ acute care patient monitoring solutions for hospitals

On Jul. 2, 2020, Royal Philips announced that the FDA had issued an Emergency Use Authorization (EUA) for…

Read More FDA issued Emergency Use Authorization for Philips’ acute care patient monitoring solutions for hospitalsContinue

ViiV Healthcare announced FDA approval for Rukobia (fostemsavir), a first-in-class treatment for HIV in adults
FDA | HIV | Life Science History

ViiV Healthcare announced FDA approval for Rukobia (fostemsavir), a first-in-class treatment for HIV in adults

On Jul. 2, 2020, ViiV Healthcare, a GSK company, with Pfizer and Shionogi Limited, announced the FDA had…

Read More ViiV Healthcare announced FDA approval for Rukobia (fostemsavir), a first-in-class treatment for HIV in adultsContinue

MediciNova announced IND for MN-166 (ibudilast) for prevention of ARD Syndrome in patients with COVID-19
COVID-19 | FDA | Life Science History

MediciNova announced IND for MN-166 (ibudilast) for prevention of ARD Syndrome in patients with COVID-19

On Jul. 1, 2020, MediciNova announced that the Investigational New Drug Application (IND) for MN-166 (ibudilast) for prevention…

Read More MediciNova announced IND for MN-166 (ibudilast) for prevention of ARD Syndrome in patients with COVID-19Continue

T2 Biosystems announces US launch of COVID-19 diagnostic test
COVID-19 | FDA | Life Science History

T2 Biosystems announces US launch of COVID-19 diagnostic test

On Jul. 1, 2020, T2 Biosystems announced completion of validation of its COVID-19 molecular diagnostic test, the T2SARS-CoV-2…

Read More T2 Biosystems announces US launch of COVID-19 diagnostic testContinue

InBios received FDA Emergency Use Authorization for second COVID-19 antibody test
Biotechnology | COVID-19 | Diagnostics | FDA

InBios received FDA Emergency Use Authorization for second COVID-19 antibody test

On Jul. 1, 2020, InBios announced that it had received Emergency Use Authorization (EUA) from the FDA for…

Read More InBios received FDA Emergency Use Authorization for second COVID-19 antibody testContinue

Successful first harvest provided roadmap for scaling secure, domestic source of farm-raised salmon
Biotechnology | FDA | Marine Science

Successful first harvest provided roadmap for scaling secure, domestic source of farm-raised salmon

On Jun. 30, 2020, AquaBounty Technologies announced it had successfully commenced the commercial-scale harvest of conventional Atlantic salmon…

Read More Successful first harvest provided roadmap for scaling secure, domestic source of farm-raised salmonContinue

Luminex submitted Emergency Use Authorization request to FDA for COVID-19 antibody test
Biotechnology | Disease | FDA

Luminex submitted Emergency Use Authorization request to FDA for COVID-19 antibody test

On Jun. 29, 2020, Luminex announced that the company had submitted an Emergency Use Authorization request to the…

Read More Luminex submitted Emergency Use Authorization request to FDA for COVID-19 antibody testContinue

The FDA approved new therapy for Dravet Syndrome
Biotechnology | FDA | Therapeutics

The FDA approved new therapy for Dravet Syndrome

On Jun. 25, 2020, the U.S. Food and Drug Administration (FDA) approved Fintepla (fenfluramine), a Schedule IV controlled…

Read More The FDA approved new therapy for Dravet SyndromeContinue

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