Roche four-in-one molecular test for SARS-CoV-2, Influenza A/B viruses and RSV receives U.S. FDA EUA
On Jun. 10, 2024, Roche announced that the U.S. Food and Drug Administration (FDA) had granted Emergency Use…
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Moderna received U.S. FDA approval for RSV vaccine mRESVIA
On May 31, 2024, Moderna announced that the U.S. Food and Drug Administration (FDA) had approved mRESVIA (mRNA-1345),…
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Beyfortus approved in China for the prevention of RSV disease in infants
On Jan. 4, 2024, AstraZeneca Sanofi’s Beyfortus (nirsevimab), a long-acting monoclonal antibody, was approved in China for the…
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Upsurge of respiratory illnesses reported among children in Northern China
On Nov. 23, 2023, the World Health Organization (WHO) announced that it was monitoring data from Chinese surveillance…
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CDC and FDA expedited availability of additional doses of new RSV immunization for infants
On Nov. 16, 2023, the CDC announced the release of more than 77,000 additional doses of Beyfortusﾙ (nirsevimab-alip…
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CDC expanded testing of international air traveler samples to include flu RSV, and other respiratory viruses
On Nov. 6, 2023, the U.S. Centers for Disease Control and Prevention (CDC) announced that it was conducting…
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U.S. FDA approved ABRYSVO, Pfizer’s vaccine for prevention of RSV in infants through active immunization of pregnant Individuals
On Aug. 21, 2023, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved ABRYSVO (Respiratory…
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BD received 510(k) clearance for COVID-19, influenza A/B, RSV molecular combination test
On Aug. 1, 2023, BD announced that the U.S. Food and Drug Administration (FDA) 510(k) had provided clearance…
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U.S. FDA approved new drug to prevent RSV in babies and toddlers
On Jul. 17, 2023, the U.S. Food and Drug Administration (FDA) approved AstraZeneca’s Beyfortus (nirsevimab-alip) for the prevention…
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CDC recommended RSV vaccine for older adults
On Jun. 29, 2023, the Centers for Disease Control and Prevention (CDC) endorsed the CDC Advisory Committee on…
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U.S. FDA approved ABRYSVO, Pfizer’s vaccine for prevention of RSV in older adults
On May 31, 2023, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved ABRYSVO (Respiratory…
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U.S. FDA approved first Respiratory Syncytial Virus (RSV) vaccine
On May 3, 2023, the U.S. FDA approved GlaxoSmithKline’s Arexvy as the first respiratory syncytial virus (RSV) vaccine…
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Biotechnology | FDA | Therapeutics | Vaccine
U.S. FDA approved PREVNAR 20, Pfizer’s 20-valent pneumococcal conjugate vaccine for infants and children
On Apr. 27, 2023, Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved PREVNAR 20®…
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Pfizer RSV vaccine 82% effective vs severe infection in infants, final data showed
On Apr. 5, 2023, Pfizer announced that experimental respiratory syncytial virus (RSV) vaccine was 82% effective in preventing…
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Biotechnology | COVID-19 | Diagnostics | FDA | Infectious Disease | Influenza | Vaccine
BD received FDA EUA for COVID-19, influenza A/B, RSV combination test
On Feb. 8, 2023, BD announced that it had received Emergency Use Authorization from the U.S. Food and…
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Moderna announced mRNA-1345, an investigational RSV Vaccine, met primary efficacy endpoints in phase 3 trial
On Jan. 17, 2023, Moderna announced positive topline data from its ConquerRSV Phase 3 pivotal efficacy trial of…
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U.S. Department of Health and Human Services increased access to Tamiflu through the Strategic National Stockpile
On Dec. 21, 2022, the U.S. Department of Health and Human Services (HHS), through the Administration for Strategic…
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FDA accepted for Priority Review the BLA for Pfizerﾒs Respiratory Syncytial Virus Vaccine candidate for prevention of RSV disease in older adults
On Dec. 7, 2022, Pfizer announced that the U.S. Food and Drug Administration (FDA) had accepted for priority…
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Hologic announced contract with BARDA to support IVD approval of COVID assays
On Nov. 2, 2022, Hologic announced that it had been awarded a $19 million contract from the Biomedical…
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Pfizer announced positive top-line data of phase 3 global trial for bivalent RSV vaccine candidate
On Nov. 1, 2022, Pfizer announced positive top-line data from the Phase 3 clinical trial (NCT04424316) MATISSE (MATernal…
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BD launched combination test for COVID-19, Influenza A/B and Respiratory Syncytial Virus
On Jun. 30, 2022, BD (Becton, Dickinson) announced that the BD MAX Respiratory Viral Panel (RVP), a new…
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Labcorp received EUA for first non-prescription at-home collection kit for combined COVID-19, Flu and RSV detection
On May 18, 2022, LabCorp announced the receipt of Emergency Use Authorization (EUA) from the U.S. Food and…
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Cepheid received Health Canada license for Xpert Xpress CoV-2/Flu/RSV plus
On Jan. 25, 2022, Cepheid announced that Health Canada had issued Cepheid a medical device license for Xpert…
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Cepheid received CE Mark for Xpert Xpress CoV-2/Flu/RSV plus
On Oct. 14, 2021, Cepheid announced it had received the CE mark for Xpert Xpress CoV-2/Flu/RSV plus, a…
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PerkinElmer received FDA Emergency Use Authorization for respiratory SARS-CoV-2 panel
On Oct. 7, 2021, PerkinElmer announced that the U.S. Food and Drug Administration (FDA) had issued Emergency Use…
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Cepheid received Emergency Use Authorization For SARS-CoV-2, Flu A, Flu B and RSV combination test
On Sept. 29, 2021, Cepheid announced it had received Emergency Use Authorization from the U.S. Food & Drug…
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Luminex submitted joint SARS-CoV-2 and Flu/RSV respiratory panel to FDA for Emergency Use Authorization
On Mar. 10, 2021, Luminex announced that it had submitted an Emergency Use Authorization application to the U.S….
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Abbott’s received FDA EUA for laboratory PCR assay that detects and differentiates SARS-CoV-2, Flu A, Flu B and RSV
On Mar. 5, 2021, Abbott announced the U.S. Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) for…
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Luminex received BARDA funding to support development and validation of test combining SARS-CoV-2 and Flu/RSV respiratory pane
On Feb. 19, 2021, Luminex announced that it had received $11.3 million in funding from the Biomedical Advanced…
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Cepheid received Health Canada license for SARS-CoV-2, Flu A, Flu B and RSV combination test
On Jan. 14, 2021, Cepheid that Health Canada announced that it had issued Cepheid a medical device license…
