SIGA announced Health Canada regulatory approval of Oral TPOXX
On Dec. 1, 2021, SIGA Technologies announced that Health Canada had approved oral TPOXX (tecovirimat) as an extraordinary…
INOVIO Announced Strategy to Address Omicron (B.1.1.529) and Future SARS-CoV-2 Variants
On Nov. 30, 2021, Inovio Pharma announced the company was rapidly moving to evaluate its COVID-19 DNA vaccine…
Johnson & Johnson COVID-19 vaccine fully approved by Health Canada to prevent COVID-19 in ages 18 years and older
On Nov. 24, 2021, Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) had issued Emergency…
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…
Zosano Pharma announced successful formulation of COVID-19 vaccine candidate on its microneedle patch system
On Nov. 17, 2021, Zosano Pharma announced that the Philippine Food and Drug Administration had granted emergency use…
Biotechnology | COVID-19 | FDA | 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 had submitted an Emergency Use Authorization (EUA) of its investigational oral…
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…
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…
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…
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 vaccine 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 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 | 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…
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)…
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…
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)…