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…
INOVIO announced initiation of phase 2/3 clinical trial for COVID-19 DNA vaccine candidate, INO-4800
On Nov. 16, 2020, INOVIO announced that it had received clearance from the the U.S. Food & Drug…
Innovation Pharma announced overseas regulatory filing submitted for COVID-19 clinical study
On Nov. 16, 2020, Innovation Pharmaceuticals announced that an overseas Clinical Trial Application (CTA) has been submitted to…
FDA approved Merck’s KEYTRUDA (pembrolizumab) in combination with chemo for patients with TNBC
On Nov. 13, 2020, Merck announced that the U.S. Food and Drug Administration (FDA) had approved KEYTRUDA, Merck’s…
Biotechnology | COVID-19 | FDA | Therapeutics
NeuroRx and Relief Therapeutics announce enrollment of 150 patients in phase 2b/3 trial of RLF-100™ for Critical COVID-19 with Respiratory Failure
On Nov. 13, 2020, NeuroRx and Relief Therapeutics announced that to-date, 150 patients (out of a targeted enrollment…
Biotechnology | FDA | Oncology | Therapeutics
Agilent received expanded FDA approval for PD-L1 IHC 22C3 pharmDx in triple-negative breast cancer
On Nov. 13, 2020, Agilent Technologies announced it had received U.S. Food and Drug Administration (FDA) approval for…
Biotechnology | COVID-19 | Diagnostics | FDA
Wren Laboratories launched saliva-based PCR COVID-19 test
On Nov. 12, 2020, Wren Laboratories announced that it had been granted an emergency use authorization by the…
Lilly’s neutralizing antibody bamlanivimab received FDA emergency use authorization for treatment of recently diagnosed COVID-19
On Nov. 9, 2020, the FDA granted Emergency Use Authorization (EUA) for Eli Lilly’s investigational neutralizing antibody bamlanivimab…
EUROIMMUN launched quantitative ELISA to measure SARS-CoV-2 antibodies against viral S1 protein
On Nov. 9, 2020, PerkinElmer announced that EUROIMMUN, a PerkinElmer company, had launched the Anti-SARS-CoV-2 QuantiVacTM ELISA (IgG)…
FDA authorized first test that detected neutralizing antibodies from recent or prior SARS-CoV-2 infection
On Nov. 6, 2020, the FDA authorized the first serology test that detected neutralizing antibodies from recent or…
OraSure’s DNA Genotek subsidiary received FDA EUA for its ORAcollect-RNA saliva collection device for SARS CoV-2
On Nov. 3, 2020, OraSure Technologies announced its DNA Genotek subsidiary has received Emergency Use Authorization from the…
Innovation Pharmaceuticals received pre-IND response from FDA on COVID-19 trial
On Nov. 2, 2020, Innovation Pharma announced receipt of written feedback from the FDA that is in general…
OncoSec announced FDA clearance of IND application for phase 1 clinical trial of CORVax12 vaccine candidate for COVID-19
On Oct. 29, 2020, OncoSec Medical announced that the FDA had approved the Investigational New Drug (IND) application…
AquaBounty announced Mayfield, Kentucky as location for planned 10,000 metric ton salmon farm
On Oct. 29, 2020, AquaBounty Technologies announced that it had identified Mayfield, Kentucky as the potential location for…