Meridian Bioscience received FDA Emergency Use Authorization for Revogeneﾮ SARS-CoV-2 molecular assay
On Nov. 10, 2021, Meridian Bioscience announced that their Revogeneﾮ SARS-CoV-2 assay was granted Emergency Use Authorization by…
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Moderna filed to expand the conditional Marketing Authorization for COVID-19 vaccine in the EU to include children ages 6-11 years
On Nov. 9, 2021, Moderna announced that it has submitted for a variation to the conditional marketing authorization…
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INOVIO received FDA authorization to proceed with INNOVATE phase 3 segment for COVID-19 vaccine candidate
On Nov. 9, 2021, Inovio Pharma announced that the U.S. Food and Drug Administration (FDA) provided authorization to…
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FDA authorized additional indication for BinaxNOW COVID-19 over-the-counter antigen test
On Nov. 8, 2021, The U.S. Food and Drug Administration (FDA) reissued the emergency use authorization (EUA) for…
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The FDA issued an emergency use authorization for the iHealth COVID-19 Antigen Rapid Test
On Nov. 5, 2021, the U.S. Food and Drug Administration The FDA issued an emergency use authorization (EUA)…
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U.S. FDA authorizd InteliSwabﾙ COVID-19 rapid tests for at-home testing for delta variant detection
On Nov. 2, 2021, OraSure Technologies announced that the EUA for its InteliSwabﾙ COVID-19 rapid tests had been…
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FDA cleared the first 510(k) for a COVID-19 test, the BioFire COVID-19 Test 2
On Nov. 1, 2021, the U.S. Food and Drug Administration (FDA) cleared the first 510(k) for a COVID-19…
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Moderna updated timing of U.S. Emergency Use Authorization of its COVID-19 vaccine for adolescents
On Oct. 31, 2021, Moderna announced that the U.S. Food and Drug Administration (FDA) had notified the Company…
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Pfizer and BioNTech received first U.S. FDA EUA of COVID-19 vaccine in children ages 5 through 11 years
On Oct. 29, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) had authorized…
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FDA Advisory Committee votes in favor of granting EUA for Pfizer-BioNTech Covid-19 vaccine in children 5 to <12 years
On Oct. 26, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administrationﾒs (FDA) Vaccines and…
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Moderna announced positive top line data from phase 2/3 study of COVID-19 vaccine in children 6 to 11 years of age
On Oct. 25, 2021, Moderna announced positive interim data from the Phase 2/3 study, called the KidCOVE study,…
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Moderna announced FDA authorization of booster dose of COVID-19 vaccine in the U.S.
On Oct. 20, 2021, Moderna announced that the U.S. Food and Drug Administration (FDA) had authorized for emergency…
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Johnson & Johnson COVID-19 vaccine booster shot authorized for Emergency Use by U.S. FDA
On Oct. 20, 2021, Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) had issued Emergency…
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FDA approved naloxone injection to counteract opioid overdoses
On Oct. 18, 2021, the Food and Drug Administration approved ZIMHI (naloxone hydrochloride) injection as an additional option…
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Biotechnology | FDA | HIV | Therapeutics
U.S. FDA approved expanded indication of Gilead’s Biktarvy for Treatment of HIV-1 in pediatric populations
On Oct. 18, 2021, Gilead Sciences announced that the Food and Drug Administration had approved a new low-dose…
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Biotechnology | Diagnostics | Disease | FDA | Oncology | Radiology | Therapeutics
FDA approved Roche’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer
On Oct. 15, 2021, Roche announced that the U.S. Food and Drug Administration (FDA) had approved Tecentriq (atezolizumab)…
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Moderna announced FDA Advisory Committee unanimously voted in support of EUA for booster dose of COVID-19 vaccine
On Oct. 14, 2021, Moderna confirmed that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological…
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FDA accepted REGEN-COVﾮ (casirivimab and imdevimab) for priority review for treatment and prophylaxis of COVID-19
On Oct. 14, 2021, Regeneron announced that the U.S. Food and Drug Administration (FDA) had accepted for priority…
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Merck and Ridgeback announced Submission of EUA to the FDA for Molnupiravir, an Investigational Oral antiviral medicine, for treatment of COVID-19
On Oct. 11, 2021, Merck and Ridgeback Biotherapeutics announced that Merck had submitted an Emergency Use Authorization (EUA)…
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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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COVID-19 | Diagnostics | FDA
EUROIMMUN anti-SARS-CoV-2 S1 curve ELISA received FDA Emergency Use Authorization
On Oct. 5, 2021, PerkinElmer announced that the U.S. Food and Drug Administration had provided Emergency Use Authorization…
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Johnson & Johnson submitted EUA amendment to FDA to support booster of single-shot COVID-19 vaccine
On Oct. 5, 2021, Johnson & Johnson announced it had submitted data to the U.S. Food and Drug…
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Merck and Ridgeback’s oral antiviral reduced risk of hospitalization or death for patients with COVID-19 in positive phase 3 study
On Oct. 1, 2021, Merck and Ridgeback Biotherapeutics announced that molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine,…
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FDA approved Kiteﾒs Tecartusﾮ as first and only Car T for adults with Relapsed or Refractory B-cell ALL
On Oct. 1, 2021, Kite, a Gilead Company, announced the U.S. Food and Drug Administration had granted approval…
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U.S. FDA cleared Naeotom Alpha, worldﾒs first photon-counting computer tomograph
On Sept. 30 2021, Siemens Healthineers announced the Food and Drug Administration (FDA) 510 (k) clearance of the…
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Pfizer reported positive top-line results of phase 3 study exploring coadministration of Prevnar 20 With seasonal Flu vaccine
On Sept. 29, 2021, Pfizer and BioNTech announced they had submitted data to the U.S. Food and Drug…
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Pfizer and BioNTech submitted initial data to FDA from pivotal trial of COVID-19 vaccine in children 5 to <12 years of age
On Sept. 28, 2021, Pfizer and BioNTech announced they had submitted data to the U.S. Food and Drug…
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OraSure received $13.6 million from BARDA to support InteliSwab COVID-19 rapid test 510(k) Clearance and CLIA Waiver
On Sept. 23, 2021, OraSure Technologies and the Biomedical Advanced Research Development Authority (BARDA) announced up to $13.6…
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Pfizer and BioNTech received first U.S. FDA Emergency Use Authorization of a COVID-19 vaccine booster
On Sept. 23, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) has authorized…
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Biotechnology | COVID-19 | Diagnostics | FDA
InBios received FDA EUA for COVID-19 IgG antibody rapid test
On Sept. 15, 2021, InBios announced that it had received Emergency Use Authorization from the U.S. Food and…
