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…
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…
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…
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…
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…
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…
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…
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)…
Chimerix announced FDA acceptance of NDA for brincidofovir as a medical countermeasure for smallpox
On Dec. 7, 2020, Chimerix announced that the FDA has accepted the filing of a New Drug Application…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
Bellerophon announced results of interim analysis of phase 3 COViNOX study of INOpulseﾮ for COVID-19
On Nov. 23, 2020, Bellerophon Therapeutics announced that the independent Data Monitoring Committee (DMC) had completed its pre-specified…
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…
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…
Eiger announced FDA approval of Zokinvyﾙ (lonafarnib) treatment for Hutchinson-Gilford Progeria Syndrome
On Nov. 20, 2020, Eiger BioPharmaceuticals announced that the FDA had approved ZokinvyTM (lonafarnib) for the treatment of…
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…
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…
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…
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…
FDA authorized first COVID-19 test for self-testing at home
On Nov. 17, 2020, the FDA issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test…
Biotechnology | COVID-19 | FDA | Therapeutics
RedHill’s second COVID-19 candidate cleared by FDA for phase 2/3 Study in symptomatic COVID-19 disease
On Nov. 17, 2020, RedHill Biopharma announced that the U.S. Food and Drug Administration (FDA) had cleared the…