FDA announced that the agency will temporarily postpone all domestic routine surveillance facility inspections, those conducted every few years based on a risk analysis.

On March 5, 2020, Amicus Therapeutics announced the official opening of its new Global Research and Gene Therapy Center of Excellence in Philadelphia, PA, to advance its portfolio of rare disease gene therapy programs.

A new test being developed by Austin, TX-based Astrotech could detect coronavirus (COVID-19) and other lung diseases from the metabolites found in a person’s breath.

Thermo Fisher Scientific is bringing its diagnostic detects nucleic acid from SARS-CoV-2, the virus that causes COVID-19, to Europe. The Waltham, MA-based company said earlier today it had received CE mark for the test.

We are in a challenging time as the COVID-19 pandemic rapidly accelerates in New York City.

Outpatient testing must not be encouraged, promoted or advertised.

Co-Diagnostics has been part of the coronavirus conversation for the past two months.

Reorg Research reported that Medtronic is in early-stage acquisition talks with LivaNova, news that has been well received by LivaNova shareholders.

FDA is upping its response to address the novel coronavirus outbreak.

Quest Diagnostics joins the growing number of firms that have developed tests for the coronavirus (COVID-19) in recent weeks.

The US Food and Drug Administration on Friday granted Emergency Use Authorization to Luminex for the firm's NxTag CoV Extended Panel to detect SARS-CoV-2 virus nucleic acids in nasopharyngeal swab specimens.

Avellino Labs on March 25 received Emergency Use Authorization for its coronavirus real-time PCR diagnostic test from the US Food and Drug Administration.

Sysmex said Friday it has obtained marketing approval in Japan for the distribution of BGI Genomics' 2019-nCoV Fluorescence Detection Real-Time RT-PCR Kit.

Fosun Pharmaceutical said on Thursday that its Fosun Long March Medical Science subsidiary has received emergency approval from China's National Medical Products Administration for a SARS-CoV-2 detection kit.

PerkinElmer said after the close of the market on Tuesday that the US Food and Drug Administration has issued Emergency Use Authorization for the firm's coronavirus RT-PCR test.