FDA granted IND approval for phase 2 clinical trial of Innovation Pharmasﾒ Brilacidin for treating COVID-19
On Dec. 21, 2020, Innovation Pharma announced that the FDA had approved the Companyﾒs Investigational New Drug (IND)…
FDA granted IND approval for phase 2 clinical trial of Innovation Pharma’s Brilacidin for treating COVID-19
On Dec. 21, 2020, Innovation Pharmaceuticals announced that the FDA had approved the Companyﾒs Investigational New Drug (IND)…
OraSure updated Its Emergency Use Authorization application for lab-based oral SARS-CoV-2 antibody test
On Dec. 21, 2020, OraSure Technologies disclosed that the FDA had requested additional information as part of its…
FDA approved prosthetic implant for above-the-knee amputations
On Dec. 18, 2020, the FDA approved the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System,…
FDA approved first adjuvant therapy for most common type of lung cancer
On Dec. 18, 2020, the FDA approved AstraZeneca’s Tagrisso (osimertinib) as the first adjuvant treatment for patients with…
FDA approved first oral hormone therapy for teating advanced prostate cancer
On Dec. 18, 2020, tthe U.S. Food and Drug Administration approved Orgovyx (relugolix) for the treatment of adult…
FDA issued Emergency Use Authorization for second COVID-19 vaccine
On Dec. 18, 2020, the FDA issued an emergency use authorization (EUA) for the second vaccine for the…
Moderna announced FDA authorization of Moderna COVID-19 vaccine in US
On Dec. 18, 2020, Moderna announced that the FDA had authorized the emergency use of mRNA-1273, Modernaﾒs vaccine…
Moderna received FDA Advisory Committee vote supporting EUA for vaccine against COVID-19 in the US
On Dec. 17, 2020, Moderna confirmed that the FDA Vaccines and Related Biological Products Advisory Committee recommended that…
ACON Laboratories received Emergency Use Authorization for its SARS-COV-2 IgG/IgM rapid test
On Dec. 17, 2020, ACON Laboratories announced that its SARS-COV-2 IgG/IgM Rapid Test has been authorized for emergency…
Abbott’s BinaxNOW COVID-19 rapid rest received FDA Emergency Use Authorization for at-home rapid test
On Dec. 16, 2020, Abbott announced that the FDA had issued Emergency Use Authorization (EUA) for virtually guided…
Meridian received NIH award for supporting rapid development of Revogeneﾮ molecular test for SARS-CoV-2
On Dec. 16, 2020, Meridian Bioscience announced that it had been awarded funding in the amount of approximately…
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…
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 approved the a first-of-its-kind intentional genomic alteration (IGA)…
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)…
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…
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…
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 Elecsysﾮ 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 Elecsysﾮ 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…
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…