China has been engaged in the R&D and manufacturing of semi-automatic coagulation analyzers for over a decade, and based on the data from the website of the NMPA, in 2024 and 2025 (as od 15 August), a total of 2 instruments from 2 manufacturers have obtained registration certificates...

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China. Latest news

NEW YORK Avellino Labs on March 25 received Emergency Use Authorization for its coronavirus real-time PCR diagnostic test from the US Food and Drug Administration. The assay, called AvellinoCoV2 test, is designed for the detection of nuclei

NEW YORK 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. Financial and other terms of the agreement were not disclosed. Sysmex said t

NEW YORK Fosun Pharmaceutical said on Thursday that its Fosun Long March Medical Science subsidiary has received emergency approval from Chinas National Medical Products Administration for a SARS-CoV-2 detection kit. According to Shanghai,

New York PerkinElmer said after the close of the market on Tuesday that the US Food and Drug Administration has issued Emergency Use Authorization for the firms coronavirus RT-PCR test. CLIA-certified labs can immediately use the PerkinElme

NEW YORK Mesa Biotech said on Tuesday that it has received Emergency Use Authorization from the US Food and Drug Administration for its Accula SARS-CoV-2 test. The PCR test is designed for the qualitative visual detection of nucleic acid fr

Human coronaviruses (HCoVs) in the past were considered to cause nothing more than the common cold in healthy people. That changed with the advent of severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndr

Synairgen, a respiratory drug discovery and development company, has announced in a March 18, 2020 press release, that it has received expedited approvals to conduct a trial of its inhaled formulation of interferon-beta-1a, SNG001, in COVID

Defects on the glass surface are a major cause of occasional breakage of the primary packaging container during fill and finish or transport. Scratches and cracks are only some of the weak points that can occur to container breakage when me

Following reports that hydroxychloroquine and chloroquine are under evaluation in clinical trials as a potential treatment of COVID-19, drug companies are donating doses and planning for ramping up supply. Bayer announced in aMarch 19, 2020

On March 23, 2020, FDA announced that on March 18, FDA and the European Medicines Agency (EMA) co-chaired the first global regulators meeting to discuss regulatory strategies to streamline vaccine development for SARS-CoV-2, which causes th