The US Dept of Veterans Affairs anounced new clinical trial for Veterans with COVID-19
On Aug. 28, 2020, the U.S. Department of Veterans Affairs (VA) announced a new clinical trial to study…
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Biotechnology | COVID-19 | FDA | Infectious Disease | Therapeutics | WHO
Laurent Pharmaceuticals received FDA approval to initiate its COVID-19 phase 2 clinical trial in the U.S.
On Aug. 27, 2020, Laurent Pharmaceuticals announced that it had received approval from the U.S. Food and Drug…
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Abbott’s fast, $5, 15-minute, easy-to-use COVID-19 antigen test for healthcare professionals received FDA Emergency Use Authorization
On Aug. 26, 2020, Abbott announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use…
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Biotechnology | COVID-19 | FDA | Therapeutics
XBiotech announced COVID-19 candidate therapy
On Aug. 24, 2020, XBiotech announced that the U.S. Food and Drug Administration (FDA) issued an emergency use…
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FDA issued Emergency Use Authorization for convalescent plasma as potential promising COVID-19 treatment
On Aug. 23, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for…
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Mayo Clinic discontinued enrollment in Expanded Access Program for convalescent plasma with FDA Emergency Use Authorization
On Aug. 23, 2020, the Mayo Clinic announced that with the FDA Emergency Use Authorization of convalescent plasma,…
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FDA approved teatment for rare disease affecting optic nerves, spinal cord
On Aug. 17, 2020, the U.S. Food and Drug Administration (FDA) approved Genentech’s Enspryng (satralizumab-mwge) for the treatment…
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FDA issued Emergency Use Authorization to Yale School of Public Health for SalivaDirect method of saliva sample processing
On Aug. 15, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to…
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Baxter obtained FDA Emergency Use Authorizations for HF20 set and ST set used in CRRT during Covid-19 pandemic
On Aug. 12, 2020, Baxter announced it had received Emergency Use Authorizations (EUAs) from the FDA for the…
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FDA approved targeted treatment for rare Duchenne Muscular Dystrophy mutation
On Aug. 12, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to NS Pharma’s Viltepso…
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Hologic launched validated pooling protocol for COVID-19 testing
On Aug. 11, 2020, Hologic announced that it has validated use of its Aptima® and Panther Fusion® molecular…
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Gilead submited New Drug Application to FDA for Veklury (Remdesivir) for treatment of COVID-19
On Aug. 10, 2020, Gilead Sciences announced that it had submitted a New Drug Application (NDA) to the…
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Biotechnology | Disease | FDA | Therapeutics
FDA approved oral treatment for spinal muscular atrophy
On Aug. 7, 2020, the U.S. Food and Drug Administration (FDA) approved Genentech’s Evrysdi (risdiplam) to treat patients…
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FDA approved two emergency INDs for COVID-19 outpatient therapy
On Aug. 6, 2020, Organicell Regenerative Medicine, a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies,…
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Johnson & Johnson announces agreement with US Government for 100 million doses of investigational COVID-19 vaccine
On Aug. 5, 2020, Johnson & Johnson announced a $1 billion agreement with the U.S. government for the…
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Biotechnology | COVID-19 | Diagnostics | FDA
Precipio launched Covid-19 antibody test in its CLIA laboratory
On Aug. 4, 2020, Precipio announced it had completed the internal validation of the U.S. Food and Drug…
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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…
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FDA approved new indication for drug containing an active Cannabis ingredient to treat seizures in rare genetic disease
On Jul. 31, 2020, the U.S. Food and Drug Administration (FDA) announced it had approved Epidiolex (cannabidiol) [CBD]…
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RedHill Biopharma initiated global phase 2/3 study for COVID-19
On Jul. 30, 2020, RedHill Biopharma announced that it has initiated a global Phase 2/3 clinical study evaluating…
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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,…
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Biotechnology | COVID-19 | Diagnostics | FDA | Therapeutics
LabCorp announced work wth public health authorities on no-charge antibody test program to accelerate COVID-19 blood plasma donation
On Jul. 30, 2020, LabCorp launched the LabCorp At Home COVID-19 Test Collection Service, the first seamless digital…
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PharmaCyte Biotech received CE Mark for licensed COVID-19 molecular tests
On Jul. 29, 2020, PharmaCyte Biotech announced that the COVID-19 Molecular tests it has licensed from Hai Kang…
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FDA authorized Quest Diagnostics lab method designed to increase COVID-19 molecular diagnostics capacity
On Jul. 29, 2020, Quest Diagnostics announced that the U.S. Food and Drug Administration (FDA) has granted emergency use…
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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…
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LabCorp received authorization for COVID-19 sample pooling
On Jul. 25, 2020, LabCorp announced it received an Emergency Use Authorization from the FDA permitting diagnostic testing…
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Biotechnology | COVID-19 | FDA | Infectious Disease | NIH | Vaccine
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…
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Biotechnology | COVID-19 | FDA | Infectious Disease | NIH | Vaccine
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…
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Biotechnology | Diagnostics | FDA | Oncology
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)…
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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…
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Bio-Techne announced launch of ExoCovid-19 test for detection of SARS-CoV-2 In patient samples
On Jul. 21, 2020, Bio-Techne announced that Exosome Diagnostics, a Bio-Techne brand, had completed validation testing for COVID-19…
