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 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
On March 23, 2020, Eli Lilly and Company provided an update on the companys clinical trial activities in light of the COVID-19 pandemic. The company will delay most new study starts and pause enrollment in most ongoing studies. Lilly is con
NEW YORK BioMrieux said on Tuesday that an assay developed by its subsidiary BioFire Defense to rapidly detect COVID-19, the disease caused by SARS-CoV-2 virus, was granted Emergency Use Authorization by the US Food and Drug Administration.
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