Thermo Fisher Scientific response to COVID-19 expanded to include new serology test
On May 13, 2020, Thermo Fisher Scientific announced it will expand its response to the COVID-19 pandemic by…
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Abbott received FDA Emergency Use Authorization for COVID-19 Molecular Test on New Alinity mﾙ System
On May 12, 2020, Abbott announced the U.S. Food and Drug Administration (FDA) had issued an Emergency Use…
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Moderna received FDA Fast Track Designation for mRNA vaccine (mRNA-1273) against novel Coronavirus
On May 12, 2020, Moderna announced the U.S. Food and Drug Administration (FDA had granted Fast Track designation…
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FDA further expanded EUA for Thermo Fisher Scientific’s COVID-19 diagnostic tests
On May 12, 2020, Thermo Fisher Scientific announced the FDA has further expanded emergency use authorization (EUA) for…
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Biotechnology | COVID-19 | FDA | Infectious Disease | Therapeutics | WHO
Mylan to supply investigational antiviral remdesivir for potential treatment of COVID-19
On May 12, 2020, Mylan announced, as part of its ongoing efforts to support patients and public health…
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Biotechnology | COVID-19 | FDA | Infectious Disease | NIH | Vaccine
NIH report coordinated strategy to accelerate multiple COVID-19 vaccine candidates is key
On May 11, 2020, a harmonized and collaborative approach to the clinical testing, scale-up and distribution of candidate…
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Abbott received FDA Emergency Use Authorization for COVID-19 Antibody Blood Test on Alinity i System
On May 11, 2020, Abbott announced the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA)…
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Todos Medical entered Into exclusive distribution agreement with Gnomegen and received FDA Emergency Use Authorization for COVID-19 qPCR test kits
On May 11, 2020, Todos Medical announced an exclusive distribution agreement with Gnomegen for the distribution of its…
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The FDA announced actions to accelerate development of novel prevention, treatment options for COVID-19
On May 11, 2020, the U.S. Food and Drug Administration (FDA) announced actions to accelerate the development of…
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Biotechnology | COVID-19 | Diagnostics | FDA
The FDA issued EUA for first antigen test to help in rapid detection of virus that causes COVID-19 in patients
On May 9, 2020, the U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA)…
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The FDA issued EUA for first diagnostic test using at-home collection of saliva specimens
On May 8, 2020, the U.S. Food and Drug Administration (FDA) announced it had issued the first emergency…
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RedHill Biopharma received FDA approval for COVID-19 clinical study with opaganib in the U.S.
On May 8, 2020, RedHill Biopharma announced the U.S. Food and Drug Administration (FDA) had approved its Investigational…
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Biotechnology | CDC | COVID-19 | Diagnostics | FDA | Infectious Disease
Quidel’s received Emergency Authorization for Rapid Antigen COVID-19 diagnostic assay
On May 8, 2020, Quidel announced it had received Emergency Use Authorization (EUA) from the FDA to market…
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Biotechnology | COVID-19 | Diagnostics | FDA | Infectious Disease | Medical Device | Non-Profit Research
OPTI Medical Systems received FDA Emergency Use Authorization for OPTI SARS-CoV-2 RNA PCR test kit for detection of Virus causing COVID-19
On May 7, 2020, OPTI Medical Systems, an IDEXX Laboratories subsidiary announced the U.S. Food and Drug Administration…
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3M and Ford begin shipping newly designed powered air-purifying respirators for health care workers fighting COVID-19
On May 6, 2020, 3M and Ford announced that newly designed powered air-purifying respirators (PAPRs), developed are on…
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Biotechnology | Diagnostics | Disease | FDA | Oncology | Therapeutics
FDA approved first targeted therapy to treat aggressive form of lung cancer
On May 6, 2020, the U.S. Food and Drug Administration (FDA) approved Tabrecta (capmatinib) for the treatment of…
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PharmaCyte Biotech received medical devices registration and submited pre-EUA application to the FDA for COVID-19 diagnostic kit
On May 6, 2020, PharmaCyte Biotech announced it had received Medical Devices Establishment Registration with the U.S. Food and…
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ACON Laboratories announced international availability of SARS-CoV-2 rapid test
On May 5, 2020, ACON Laboratories announced the availability of its SARS-COV-2 IgG/IgM Rapid Test. ACON’s test is…
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BIOFIRE respiratory panel 21 (RP21) with SARS-CoV-2 obtained FDA Emergency Use Authorization
On May 4, 2020, bioMerieux announced that BioFire Diagnostics, its subsidiary specialized in syndromic infectious disease testing, has…
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Vir and Alnylam identified RNAi therapeutic development candidate, VIR-2703 (ALN-COV), targeting SARS-CoV-2 for treatment of COVID-19
On May 4, 2020, Vir Biotech and Alnylam Pharma announced the selection of a development candidate for VIR-2703,…
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Cerus announced FDA approval for INTERCEPT Blood System for plasma with alternate plastic disposable kits
On May 4, 2020, Cerus announced U.S. Food and Drug Administration (FDA) regulatory approval for manufacture of INTERCEPT…
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DNA Genotek’s ORAcollect RNA kit included in EUA granted to Biocerna SARS-CoV-2 test
On May 4, 2020, DNA Genotek, a subsidiary of OraSure Technologies, announced that its ORAcollect RNA kit (OR-100)…
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Roche’s COVID-19 antibody test received FDA Emergency Use Authorization and is available in markets accepting the CE mark
On May 2, 2020, Roche announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency…
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Gilead announced investigational antiviral remdesivir received FDA Emergency Use Authorization for treatment of COVID-19
On May 1, 2020, Gilead announced that the U.S. Food and Drug Administration (FDA) has granted emergency use…
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FDA issued Emergency Use Authorization for potential COVID-19 treatment
On May 1, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for…
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FDA approved DARZALEX FASPRO, a new subcutaneous formulation of Daratumumab in treatment of patients with Multiple Myeloma
On May 1, 2020, the Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (DARZALEX FASPRO, Janssen Biotech.)…
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FDA included ventilator developed by NASA in ventilator Emergency Use Authorization
On Apr. 30, 2020, the FDA included, under the ventilator emergency use authorization (EUA), a ventilator developed by…
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Chimerix received FDA clearance for rolling submission of New Drug Application for brincidofovir as medical countermeasure for smallpox
On Apr. 28, 2020, Chimerix announced it had received clearance from the FDA for a rolling submission of…
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Diffusion Pharma announced pre-IND submission to FDA of design for TSC trials to treat Acute Respiratory Distress Syndrome in COVID-19
On Apr. 27, 2020, Diffusion Pharmaceuticals announced the pre-IND submission to the FDA of a planned clinical program…
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Biotechnology | COVID-19 | FDA | Therapeutics
Mateon announced filing of IND with FDA to evaluate antisense drug candidate OT-101 in COVID-19 patients
On Apr. 27, 2020, Mateon Therapeutics announced announced it has submitted an Investigational New Drug application to the…
