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…
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…
FDA declined Humanigenﾒs Emergency Use Authorization request for lenzilumab in hospitalized COVID-19 patients
On Sept. 9, 2021, Humanigen announced the U.S. FDA had declined its request for emergency use authorization of…
AIM ImmunoTech submitted pre-IND application to FDA for phase 2 clinical study of Ampligen for post-COVID-19 cognitive dysfunction
On Sept. 8, 2021, AIM ImmunoTech announced that is had submitted a Pre-Investigational New Drug application (Pre-IND) to…
Pfizer and BioNTech submitted a variation to EMA with data in support of a booster dose of COMIRNATY
On Sept. 6, 2021, Pfizer and BioNTech announced that they had submitted a variation to the European Medicines…
Moderna announced submission of initial data to U.S. FDA for Its COVID-19 vaccine booster
On Sept. 1, 2021, Moderna announced it had initiated its submission to the U.S. Food and Drug Administration…
Moderna completed submission of BLA to the Food and Drug Administration for its COVID-19 vaccine
On Aug. 25, 2021, Moderna announced it had completed the rolling submission process for its Biologics License Application…
BD received EUA for first at-home COVID-19 test to use smartphone to interpret, deliver results
On Aug. 25, 2021, BD (Becton, Dickinson) announced the U.S. Food and Drug Administration (FDA) had issued an…
Pfizer and BioNTech initiated rolling submission of SBLA to U.S. FDA for booster dose of COMIRNATY in individuals 16 and Older
On Aug. 25, 2021, Pfizer and BioNTech announced the initiation of a supplemental Biologics License Application (sBLA) to…
U.S. FDA approved first COVID-19 vaccine
On Aug. 23, 2021, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine, known…
Pfizer-BioNTech COVID-19 vaccine COMIRNATY received full U.S. FDA approval for individuals 16 years and older
On Aug. 23, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) approved the…
ADMA Biologics received FDA approval for plasma collection facility in Maryville, TN
On Aug. 16, 2021, ADMA Biologics announced that it had received U.S. Food and Drug Administration approval for…
Pfizer and BioNTech announced submission of initial data to FDA to support booster dose of COVID-19 vaccine
On Aug. 16, 2021, Pfizer and BioNTech announced that they had submitted Phase 1 data to the U.S….
FDA approved Merck’s hypoxia-inducible factor-2 alpha inhibitor WELIREG (belzutifan)
On Aug. 13, 2021, Merck announced that the U.S. Food and Drug Administration (FDA) had approved WELIREG, an…
COVID-19 | FDA | Life Science History | NIH
FDA declined to issue Rigel Pharma EUA for fostamatinib for teatment of COVID-19 in hospitalized adults
On Aug. 13, 2021, Rigel Pharma announced that the U.S. Food and Drug Administration (FDA) had informed the…
Moderna announced FDA authorization of third dose of COVID-19 vaccine for immunocompromised individuals
On Aug. 13, 2021, Moderna announced that the Food and Drug Administration (FDA) had approved an update to…
U.S. FDA approved TICOVACﾙ, Pfizerﾒs tick-borne encephalitis vaccine
On Aug. 13, 2021, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved TICOVACﾙ (tick-borne…
Moderna received FDA Fast Track Designation for Respiratory Syncytial Virus vaccine
On Aug. 3, 2021, Moderna announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track…
FDA expanded authorized use of REGEN-COVﾙ (casirivimab and imdevimab)
On Jul. 30, 2021, Regeneron announced that the FDA had updated the Emergency Use Authorization (EUA) for the…
FDA broadened existing EUA of Lilly and Incyte’s baricitinib in patients hospitalized with COVID-19
On Jul. 29, 2021, Incyte announced the U.S. Food and Drug Administration (FDA) had broadened the Emergency Use…
FDA Approved Expanded BOTOX® Label to Include Eight New Muscles to Treat Adults with Upper Limb Spasticity
On Jul. 29, 2021, BOTOX(R) Allergan, an AbbVie company, announced that the U.S. Food and Drug Administration (FDA)…
Emergent BioSolutions resumed manufacturing COVID-19 vaccine at Bayview facility
On Jul. 29, 2021, Emergent BioSolutions announced that the FDA had begun allowing Emergent’s Bayview manufacturing facility to…
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The COVID-19 Vaccine
Cast of Characters: Donald Trump, President | Mike Pence, Vice President | Anthony S. Fauci, MD, Director, National…
Merck Announces FDA approval of VAXNEUVANCE for prevention of invasive pneumococcal disease
On Jul. 16, 2021, Merck announced the U.S. Food and Drug Administration (FDA) had approved VAXNEUVANCE (Pneumococcal 15-valent…
U.S. FDA granted Priority Review for Biologics License Application for Pfizer-BioNTech COVID-19 vaccine
On Jul. 16, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) had granted…
U.S. FDA announced revisions JNJ COVID-19 Vaccine fact sheets to include information pertaining to Guillain-Barre Syndrome
On Jul. 13, 2021, the Food and Drug Administration (FDA) revisions to the vaccine recipient and vaccination provider…
U.S. FDA issued an EUA to Ortho-Clinical Diagnostics for VITROS Anti-SARS-CoV-2 IgG quantitative test
On Jul. 9, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to Ortho-Clinical…
U.S. FDA authorized an EUA for the Janssen COVID-19 vaccine manufacture at Emergent facility
On Jul. 2, 2021, the Food and Drug Administration (FDA) authorized the use, under the emergency use authorization…
Meridian resubmitted application to FDA for Emergency Use Authorization for Revogeneﾮ SARS-CoV-2 molecular assay
On Jun. 28, 2021, Meridian Bioscience announced that it had re-submitted its application for Emergency Use Authorization (EUA)…
Rocheﾒs Actemra/RoActemra received FDA EUA for treatment of COVID-19 in hospitalised adults and children
On Jun. 25, 2021, Roche announced that the Food and Drug Administration (FDA) has issued an Emergency Use…