OraSure’s OMNIgene-ORAL device included in EUA granted to Clinical Reference Laboratory for self-collected SARS saliva test
On Jul. 31, 2020, OraSure Technologies announced that its OMNIgene-ORAL (OM-505) saliva collection device is included in the…
Biotechnology | COVID-19 | FDA
Precipio announced commercial launch of Covid-19 antibody test
On Jul. 30, 2020, Precipio announced it had entered into an agreement with ADS Biotec, based in Omaha,…
LabCorp announced work wth public health authorities on no-charge antibody test program to accelerate COVID-19 blood plasma donation
On Jul. 30, 2020, LabCorpﾮ launched the LabCorp At Home COVID-19 Test Collection Service, the first seamless digital…
FDA authorized Quest Diagnostics lab method designed to increase COVID-19 molecular diagnostics capacity
On Jul. 29, 2020, Quest Diagnostics announced that the FDA had granted emergency use authorization for a new…
BARDA procured Regeneron’s REGN-EB3 investigational Ebola treatment for national preparedness
On Jul. 29, 2020, Regeneron announced that the Biomedical Advanced Research and Development Authority (BARDA) had entered into…
LabCorp received authorization for COVID-19 sample pooling
On Jul. 25, 2020, LabCorpﾮ announced it received an Emergency Use Authorization from the FDA permitting diagnostic testing…
Biotechnology | COVID-19 | FDA
Dynavax and Medigen announced collaboration to develop a novel adjuvanted COVID-19 vaccine candidate
On Jul. 23, 2020, Dynavax Technologies and Medigen Vaccine Biologics announced their collaboration to develop an adjuvanted vaccine…
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…
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…
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)…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…