FDA authorized InBios COVID-19 over-the-counter antigen test
On Nov. 22, 2021, the U.S. Food and Drug Administration authorized another over-the-counter (OTC) COVID-19 antigen test. The…
FDA announced FDA authorization of Moderna’s booster dose of COVID-19 vaccine in the U.S. for adults 18 years and older
On Nov. 19, 2021, the U.S. Food and Drug Administration (FDA) announced that it had extended the emergency…
Pfizer and BioNTech received expanded U.S. FDA EUA of COVID-19 vaccine booster to include individuals 18 and older
On Nov. 19, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) had expanded…
Pfizer provided U.S. Government with 10 million treatment courses of oral antiviral candidate to help combat COVID-19
On Nov. 18, 2021, Pfizer announced an agreement with the U.S. government to supply 10 million treatment courses…
Biotechnology | COVID-19 | FDA | Life Science News | Therapeutics | Vaccine
GSK and Vir Biotechnology announced U.S. government agreements to purchase sotrovimab, a COVID-19 treatment
On Nov. 17, 2021, GlaxoSmithKline and Vir Biotechnology announced U.S. government contracts totalling approximately $1 billion (USD) to…
Pfizer submitted Emergency Use Authorization for novel COVID-19 oral antiviral candidate
On Nov. 16, 2021, Pfizer announced it announced it had submitted an Emergency Use Authorization (EUA) of its…
Innovation Pharmaceuticals announced topline results from phase 2 clinical trial of brilacidin for COVID-19
On Nov. 11, 2021, Innovation Pharma reported topline results from the Companyﾒs Phase 2 clinical trial of Brilacidin…
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…
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 provided authorization to proceed…
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…
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)…
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…
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…
Moderna updated timing of U.S. Emergency Use Authorization of its COVID-19 vccine for adolescents
On Oct. 31, 2021, Moderna announced that the U.S. Food and Drug Administration (FDA) had notified the Company…
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…
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…
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,…
Moderna announced FDA authorization of booster dose of Moderna’s 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…
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…
Biotechnology | FDA | HIV | Life Science News | 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…
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…
FDA approved Rocheﾒs Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer
On Oct. 15, 2021, Roche announced that the US Food and Drug Administration (FDA) had approved Tecentriqﾮ (atezolizumab)…
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ﾒs (FDA) Vaccines and Related Biological…
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…
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)…
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…
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…
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,…
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…
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…