FDA authorized antigen test as first over-the-counter fully at-home diagnostic test for COVID-19
On Dec. 15, 2020, the FDA granted emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home…
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FDA approved first-of-its-kind Intentional genomic alteration in Line of domestic pigs for human food, potential therapeutic uses
On Dec. 14, 2020, the U.S. Food and Drug Administration (FDA) approved the a first-of-its-kind intentional genomic alteration…
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Biotechnology | CRISPR | FDA | Therapeutics
CIRM-funded project targeting sickle cell disease received green light for clinical trial
On Dec.14, 2020, the US Food and Drug Administration (FDA) announced they had granted Investigational New Drug (IND)…
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FDA approved first intentional genomic alteration in domestic pigs for both human food, potential therapeutic uses
On Dec. 14, 2020, the U.S. Food and Drug Administration approved a first-of-its-kind intentional genomic alteration (IGA) in…
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US FDA issued Emergency Use Authorization for first COVID-19 vaccine
On Dec. 11, 2020, the FDA issued the first emergency use authorization (EUA) for a vaccine for the…
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COVID-19 | FDA | Therapeutics
Data from ACTT-2 trial of Baricitinib in hospitalized COVID-19 patients supportive of the EUA published in NEJM
On Dec. 11, 2020, Eli Lilly and Incyte announced The New England Journal of Medicine had published the…
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US Dept of Veterans Affairs announced initial plans for COVID-19 vaccine distribution
On Dec. 10, 2020, the U.S. Dept. of Veterans Affairs (VA) announced a preliminary plan for distributing COVID-19…
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Roche partnered with Moderna to include SARS-CoV-2 antibody test in ongoing COVID-19 vaccine trials
On Dec. 10, 2020, Roche announced a partnership with Moderna to utilise the Elecsys Anti-SARS-CoV-2 S antibody test…
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Pfizer and BioNTech received FDA Advisory Committee vote supporting EUA for COVID-19 vaccine in the US
On Dec. 10, 2020, Pfizer and BioNTech announced that the FDA Vaccines and Related Biological Products Advisory Committee…
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LabCorp received FDA Authorization to make at-home COVID-19 collection kits available rhrough retail
On Dec. 9, 2020, LabCorp announced that the FDA had granted Emergency Use Authorization (EUA) for the Pixel…
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Roche partnered with Moderna to include SARS-CoV-2 antibody test in ongoing COVID-19 vaccine trials
On Dec. 9, 2020, Roche announced a partnership with Moderna to utilise the Elecsys Anti-SARS-CoV-2 S antibody test…
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FDA accepted for priority review the BLA for Pfizerﾒs investigational 20-valent pneumococcal conjugate vaccine
On Dec. 8, 2020, Pfizer announced that the FDA accepted for priority review a Biologics License Application (BLA)…
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Chimerix announced FDA acceptance of NDA for brincidofovir as a medical countermeasure for smallpox
On Dec. 7, 2020, Chimerix announced the U.S. Food and Drug Administration (FDA) had accepted the filing of a…
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FDA approved Saxenda for the treatment of obesity in adolescents aged 12-17
On Dec. 4, 2020, Novo Nordisk announced that the FDA approved an updated label for Saxenda (liraglutide) injection…
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Roche received FDA Emergency Use Authorization for new test to measure level of SARS-CoV-2 antibodies
On Dec. 2, 2020, Roche announced that its Elecsysﾮ Anti-SARS-CoV-2 S antibody test had received Emergency Use Authorization…
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FDA approved first PSMA-targeted PET imaging drug for men with prostate cancer
On Dec. 1, 2020, the FDA approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) ﾖ the first drug for…
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VBI Vaccines announced submission of BLA to FDA for 3-antigen prophylactic Hepatitis B vaccine
On Dec. 1, 2020, VBI Vaccines announced the submission of a Biologics License Application (BLA) to the FDA…
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Moderna announced primary efficacy analysis in phase 3 COVE study for COVID-19 vaccine candidate
On Nov. 30, 2020, Moderna announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273…
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Altimmune announced submission of Investigational NDA for AdCOVIDﾙ a single-dose intranasal COVID-19 vaccine
On Nov. 25, 2020, Altimmune announced that it had submitted an Investigational New Drug (IND) application to the…
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Commonly used antibiotic showed promise for combating Zika infections
On Nov. 24, 2020, preclinical study by the National Institutes of Health (NIH) suggested FDA-approved tetracycline-based antibiotics may…
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FDA expanded approval of influenza treatment to post-exposure prevention
On Nov. 23, 2020, the U.S. Food and Drug Administration (FDA) expanded the approved indication for Genentech’s Xofluza…
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Merck submited applications for licensure of V114, 15-valent pneumococcal conjugate vaccine, for use in adults
On Nov. 23, 2020, Merck, known as MSD outside the U.S. and Canada, announced the company had submitted…
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Viatris announced FDA tentative approval of pediatric formulation of Dolutegravir under PEPFAR
On Nov. 23, 2020, Viatris announced tentative approval from the FDA for a New Drug Application for pediatric…
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Disease | FDA | Rare Disease
FDA approved first drug to treat rare metabolic disorder
On Nov. 23, 2020, the U.S. Food and Drug Administration (FDA) approved Alnylam Pharmaceuticals’s Oxlumo (lumasiran) as the…
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FDA authorized monoclonal antibodies for treatment of COVID-19
On Nov. 21, 2020, the FDA issued an emergency use authorization (EUA) for Regeneron Pharmaceuticals’ casirivimab and imdevimab…
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Regeneron’s REGEN-COV2 ntibody cocktail for COVID-19 received FDA Emergency Use Authorization
On Nov. 21, 2020, Regeneron announced that the antibody cocktail casirivimab and imdevimab administered together (also known as…
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Pfizer and BioNTech to submit Emergency Use Authorization Request to the FDA for COVID-19 vaccine
On Nov. 20, 2020, Pfizer and BioNTech announced they submitted a request to the Food and Drug Administration…
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Aptima HIV-1 Quant Dx assay receivds additional FDA approval for use as aAid in diagnosis of HIV infection
On Nov. 30, 2020, Hologic announced that the FDA had approved a diagnostic claim for its HIV-1 (human…
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Biotechnology | COVID-19 | FDA | Therapeutics
Baricitinib received Emergency Use Authorization from FDA for treatment of hospitalized patients with COVID-19
On Nov. 19, 2020, Eli Lilly and Incyte announced that the FDA had issued an Emergency Use Authorization…
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Todos Medical announced positive initial clinical proof-of-concept data for rapid SARS-CoV-2 3CL protease detection assay
On Nov. 18, 2020, Todos Medical announced positive clinical proof of concept data from its lab-based rapid SARS-CoV-2…
