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…
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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…
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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….
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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…
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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…
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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…
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Biotechnology | FDA | Neurology | Oncology | Therapeutics
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…
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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…
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COVID-19 | FDA | Therapeutics
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…
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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)…
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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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Biotechnology | Cartoons - Original | CDC | COVID-19 | FDA | Infectious Disease | NIH | Non-Profit Research | Vaccine
The COVID-19 Vaccine
The COVID-19 Cartoon illustrates the further politicalization of the U.S. Healthcare System. The choice between getting a vaccine,…
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Biotechnology | FDA | Medicine | Pharmaceutical | Therapeutics | Vaccine
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…
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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…
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U.S. FDA announced revisions JNJ COVID-19 Vaccine fact sheets to include information pertaining to Guillain-Barre Syndrome
On Jul. 12, 2021, the Food and Drug Administration (FDA) announced revisions to the vaccine recipient and vaccination…
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HDT Bio received notice to proceed from FDA for U.S. phase 1 clinical trial of RNA COVID-19 vaccine
On Jul. 1, 2021, HDT Bio announced the U.S. Food and Drug Administration had reviewed the companyﾒs Investigational…
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Meridian resubmitted application to FDA for Emergency Use Authorization for Revogene SARS-CoV-2 molecular assay
On Jun. 28, 2021, Meridian Bioscience announced that it had re-submitted its application for Emergency Use Authorization (EUA)…
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Biotechnology | Cartoons - Original | CDC | COVID-19 | Diagnostics | FDA | Genomics | Life Science History | Medicine | NIH | Therapeutics | U.S. Congress | Vaccine
COVID-19 PPE distribution
The COVID-19 PPE Distribution cartoon illustrates the confusion and complexity of distributing Personal Protective Equipment (PPE) to defend…
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Roche’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) had issued an Emergency Use…
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Disease | FDA | Neurology | Therapeutics
Eisai and Biogen announced FDA granted Breakthrough Therapy Designation for Lecanemab for treatment of Alzheimer’s disease
On Jun. 23, 2021, Biogen and Eisai announced that the U.S. Food and Drug Administration (FDA) had granted…
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Quidel received amended Emergency Use Authorization for new Sofia Q rapid antigen test device
On Jun. 11, 2021, Quidel announced today that it had received an amended Emergency Use Authorization (EUA) from…
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FDA issued EUA for the Janssen COVID-19 vaccine manufactured at Emergent BioSolutions facility in Baltimore
On Jun. 11, 2021, The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for…
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Moderna filed for Emergency Use Authorization for its COVID-19 vaccine in adolescents in the United States
On Jun. 10, 2021, Moderna announced that it had requested an emergency use authorization (EUA) for its COVID-19…
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Merck announced supply agreement with U.S. Government for molnupiravir, an Investigational oral antiviral treatment of COVID-19
On Jun. 9, 2021, Merck announced it had entered into a procurement agreement with the United States government…
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Vertex announces FDA approval for TRIKAFTA in children with Cystic Fibrosis ages 6 through 11 with certain mutations
On Jun. 9, 2021, Vertex Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) approved expanded use of…
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RECOVERY trial found aspirin does not improve survival for patients hospitalised with COVID-19
On Jun. 8, 2021, the University of Oxford announced the RECOVERY trial was established as a randomised clinical…
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Biotechnology | Disease | FDA | Neurology | Therapeutics
FDA granted accelerated approval for ADUHELM as the first and only Alzheimer’s disease treatment
On Jun. 7, 2021, Biogen and Eisai announced that the U.S. Food and Drug Administration (FDA) had granted…
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OraSure Technologies receives three EUA’s for its COVID-19 rapid antigen tests for non-prescription use
On Jun. 7, 2021, OraSure Technologies announced that it had received Emergency Use Authorization (EUA) from the U.S….
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FDA approved new rug treatment for chronic weight management, first since 2014
On Jun. 4, 2021, the U.S. Food and Drug Administration (FDA) announced it had approved Novo Nordisk’s Wegovy…
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Chimerix received U.S. FDA approval for TEMBEXA (brincidofovir) for treatment of smallpox
On Jun. 4, 2021, The U.S. Food and Drug Administration (FDA) approved Chimerix’s Tembexa (brincidofovir) tablets and oral…
