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…
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)…
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 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…
AquaBounty received approval for the sale of GE Atlantic Salmon in Brazil
On Jun. 1, 2021, AquaBounty Technologies announced the regulatory approval of the Company’s GE Atlantic salmon by Brazil’s…
Moderna announced rolling submission of Biologics License Application with FDA for COVID-19 vaccine
On Jun. 1, 2021, Moderna announced that it had initiated the rolling submission process with the U.S. Food…
Biotechnology | Diagnostics | Disease | FDA | Oncology | Radiology | Therapeutics
FDA approved LUMAKRAS for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer
On May 28, 2021, Amgen announced that the U.S. Food and Drug Administration (FDA) had approved LUMAKRAS (sotorasib)…
Humanigen submitted application to FDA for Emergency Use Authorization for lenzilumab in COVID-19
On May 28, 2021, Humanigen announced that the company had submitted an application to the FDA requesting Emergency…
Biotechnology | Diagnostics | FDA | Infectious Disease | NIH | Therapeutics
NIAID scientists found that Salmonella use intestinal epithelial cells to colonize the gut
On May 26, 2021, National Institutes of Health (NIH) scientists reported that the immune system’s attempt to eliminate…
GSK and Vir Biotech announced sotrovimab (VIR-7831) received EUA from the US FDA for treatment of mild-to-moderate COVID-19 in high-risk adults and paediatric patients
On May 26, 2021, GlaxoSmithKline and Vir Biotechnology announced the U.S. Food and Drug Administration (FDA) granted an…
Biotechnology | Diagnostics | Disease | FDA | Oncology | Radiology | Therapeutics
FDA approved first targeted therapy for subset of non-small cell lung cancer
On May 21, 2021, the the U.S. Food and Drug Administration (FDA) approved Rybrevant (amivantamab-vmjw) as the first…