Hologic granted FDA Emergency Use Authorization for its second molecular test for COVID-19
On May 15, 2020, Hologic announced it had received Emergency Use Authorization (EUA) from the FDA for its…
The FDA informed public about possible accuracy concerns with Abbott ID NOW point-of-care test
On May 14, 2020, the FDA alerted the public to early data that suggest potential inaccurate results from…
AIM ImmunoTech announced FDA authorization for first human ampligen trial in COVID-19 patients with cancer
On May 14, 2020, AIM ImmunoTech announced the FDA authorized the first human trial assessing the safety and…
Philips received FDA clearance for use of ultrasound portfolio to manage COVID-19-related lung and cardiac complications
On May 13, 2020, Royal Philips announced that it had received 510(k) clearance from the FDA to market…
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…
Abbott received FDA Emergency Use Authorization for COVID-19 Molecular Test on New Alinity mﾙ System
On May 12, 2020, Abbott announced the FDA issued an Emergency Use Authorization (EUA) for the company’s molecular…
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…
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…
The FDA announced actions to accelerate development of novel prevention, treatment options for COVID-19
On May 11, 2020, the FDA announced actions to accelerate the development of prevention and treatment options for…
Biotechnology | COVID-19 | FDA
Abbott received FDA Emergency Use Authorization for COVID-19 Antibody Blood Test on Alinity i System
On May 11, 2020, Abbott announced the FDA issued an Emergency Use Authorization (EUA) for the company’s SARS-CoV-2…
Biotechnology | COVID-19 | FDA | Therapeutics
Bellerophon Therapeutics submited investigational NDA to study INOpulse inhaled nitric oxide for treatment of COVID-19
On May 11, 2020, Bellerophon Therapeutics announced the FDA accepted its Investigational New Drug (IND) application, allowing the…
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…
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 8, 2020, the U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA)…
The FDA issued EUA for first diagnostic test using at-home collection of saliva specimens
On May 8, 2020, the FDA issued an emergency use authorization (EUA) to Rutgers Clinical Genomics Laboratory for…
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…
Biotechnology | CDC | COVID-19 | FDA
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…
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…
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 FDAﾒs Center…
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…
Biotechnology | COVID-19 | Diagnostics | FDA
FDA provided Emergency Use Authorization to PerkinElmer for serological test to identify COVID-19 antibodies
On May 5, 2020, PerkinElmer announced the FDA provided Emergency Use Authorization (EUA) for EUROIMMUN’s (a PerkinElmer company)…
Organicell announces FDA approval of IND application for treatment of SARS due to COVID-19
On May 5, 2020, Organicell Regenerative Medicine announced the FDA has approved the Investigational New Drug application for…
Diffusion Pharma announced FDA Accelerated Review of TSC clinical development plan to treat COVID-19 patients with ARDS
On May 5, 2020, Diffusion Pharmaceuticals announced the FDA accelerated its review of the Companyﾒs clinical development plan…
Biotechnology | COVID-19 | FDA
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…
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,…
Cerus announced FDA approval for INTERCEPT Blood System for plasma with alternate plastic disposable kits
On May 4, 2020, Cerus announced FDA regulatory approval for manufacture of INTERCEPT plasma with a new, alternative…
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)…
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 FDA has issued an Emergency Use Authorization for its new…
COVID-19 | FDA | Therapeutics
Gilead announced investigational antiviral remdesivir received FDA Emergency Use Authorization for treatment of COVID-19
On May 1, 2020, Gilead announced the FDA granted emergency use authorization (EUA) for the investigational antiviral remdesivir…
FDA issued Emergency Use Authorization for potential COVID-19 treatment
On May 1, 2020, the FDA issued an Emergency Use Authorization (EUA) for the investigational antiviral drug remdesivir…
FDA approved DARZALEX FASPRO, a new subcutaneous formulation of Daratumumab in treatment of patients with Multiple Myeloma
On May 1, 2020, Janssen Pharma, a Johnson & Johnson company, announced the U.S. Food and Drug Administration…