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…
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…
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…
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…
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…
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…
Biotechnology | Cartoons - Original | COVID-19 | Diagnostics | FDA | Life Science History | Therapeutics | Vaccine
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…
Biotechnology | COVID-19 | FDA
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…
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…
Emergent BioSolutions’ COVID-19 vaccine drug substance authorized as part of Johnson & Johnson EUA
On Jun. 11, 2021, Emergent BioSolutions announced that two batches of COVID-19 vaccine manufactured by at its Baltimore…
Quidel received amended Emergency Use Authorization for new Sofia Q rapid antigen test device
On Jun. 11, 2021, Quidel announced it had received an amended Emergency Use Authorization (EUA) from the U.S….
FDA issued EUA for the Janssen COVID-19 vaccine manufactured at Emergent BioSolutions facility in Baltimore
On Jun. 11, 2021, The FDA issued an emergency use authorization (EUA) for the Janssen COVID-19 vaccine, two…
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…
Vertex announces FDA approval for TRIKAFTAﾮ 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…
RECOVERY trial found aspirin does not improve survival for patients hospitalised with COVID-19
On Jun. 8, 2021, the University of Oxford announced that the RECOVERY trial found aspirin does not improve…
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…
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 FDA…
Chimerix received U.S. FDA approval for TEMBEXAﾮ (brincidofovir) for treatment of smallpox
On Jun. 4, 2021, Chimerix announced that the U.S. Food and Drug Administration (FDA) had granted TEMBEXAﾮ (brincidofovir)…
FDA approved new rug treatment for chronic weight management, first since 2014
On Jun. 4, 2021, the U.S. Food and Drug Administration announced it had approved Novo Nordisk’s Wegovy (semaglutide)…
FDA authorized lower 1,200 mg intravenous and subcutaneous dose of REGEN-COV antibody cocktail to treat COVID-19 patients
On Jun. 4, 2021, Regeneron announced the U.S. Food and Drug Administration (FDA) updated the Emergency Use Authorization…
Innovation Pharma completed enrollment in phase 2 clinical trial for COVID-19
On Jun. 3, 2021, Innovation Pharma announced that it had achieved full patient enrollment in its randomized, double-blind,…
Relief Therapeutics reported that NRx Pharma, had submitted an application for EUA for Aviptadil to the U.S. FDA
On Jun. 2, 2021, RELIEF THERAPEUTICS reported that its collaboration partner, NRx Pharmaceuticals, announced that it had submitted…