Novavax initiated phase 1/2 clinical trial of combination vaccine for COVID-19 and seasonal influenza
On Sept. 8, 2021, Novavax announced enrollment of the first participants in a Phase 1/2 study to evaluate…
Data from phase 2 trial of Fostamatinib in hospitalized COVID-19 patients published in Clinical Infectious Diseases
On Sept. 1, 2021, Rigel Pharma announced the publication of results from a Phase 2 clinical trial evaluating…
NIH launched study of extra COVID-19 vaccine dose in people with autoimmune disease
On Aug. 27, 2021, The National Institutes of Health announced that it had begun a clinical trial to…
clinical trial tested donated antibodies for effectiveness in fighting infection caused by Coronavirus
On Aug. 19, 2021, Oregon Health & Science University (OHSU) announced that it was part of a randomized,…
COVID-19 | FDA | Life Science History | NIH
FDA declined to issue Rigel Pharma EUA for fostamatinib for teatment of COVID-19 in hospitalized adults
On Aug. 13, 2021, Rigel Pharma announced that the U.S. Food and Drug Administration (FDA) had informed the…
Innovation Pharmaceuticals’ phase 2 clinical trial of Brilacidin for COVID-19 trial database under review in preparation for lock
On Aug. 12, 2021, Innovation Pharma released information regarding the status of its randomized, double-blind, placebo-controlled Phase 2…
Monoclonal antibody prevented malaria in small NIH trial
On Aug. 11, 2021, the National Institutes of Health (NIH) announced that one dose of a new monoclonal…
INOVIO and Advaccine receive regulatory allowance for prime-boost clinical trials in China using INO-4800, COVID-19 DNA vaccine candidate
On Aug. 9, 2021, Inovio Pharma announced that it had received regulatory allowance for two clinical trials investigating…
CytoDyn received clearance from Brazil’s FDA (ANVISA) to commence pivotal phase 3 trial in critically ill COVID-19 patients
On Aug. 3, 2021, CytoDyn announced that Brazil’s regulatory authority ANVISA (Agência Nacional de Vigilância Sanitária) has approved…
FDA cleared Vaxart’s IND application for S-only oral tablet COVID-19 vaccine candidate
On Aug. 2, 2021, Vaxart announced that the U.S. Food and Drug Administration had cleared Vaxart’s Investigational New…
NIH unveiled new online tool to improve Alzheimer’s clinical trials recruitment
On Jul. 29, 2021, the National Institutes of Health announced it had launched a new online research tool…
Vaxart reported boosting immune responses in subjects previously vaccinated by a Vaxart vaccine
On Jul. 29, 2021, Vaxart announced that it had shown for the first time in clinical trials that…
Sorrento announced dosing of COVID-19 patients in phase 2 clinical trial for COVIDROPS neutralizing antibody against SARS-CoV-2
On Jul. 21, 2021, Sorrento Therapeutics announced that COVID-19 patients had been dosed in its Phase 2 efficacy…
Corvus discontinued phase 3 study of mupadolimab for COVID-19 due to vaccine effectiveness in reducing hospitalizations
On Jul. 15, 2021, Corvus Pharmaceuticals announced that it had discontinued its Phase 3 study of mupadolimab for…
WHO recommended interleukin-6 receptor blockers for COVID-19 and urged producers to join efforts to rapidly increase access
On Jul. 6, 2021, the World Health Organization announced updated patient care guidelines to include interleukin-6 receptor blockers,…
HDT Bio received notice to proceed from FDA for U.S. phase 1 clinical trial of RNA COVID-19 vaccine
On Jul. 1, 2021, HDT Bio announced the U.S. Food and Drug Administration had reviewed the companyï¾’s Investigational…
Investigational malaria vaccine gives strong, lasting protection
On Jun. 30, 2021, the National Institutes of Health announced that two U.S. Phase 1 clinical trials of…
Novavax published results of UK phase 3 clinical trial in NEJM, demonstrating high levels of efficacy of COVID-19 vaccine
On Jun. 30, 2021, Novavax announced the publication of results from the final analysis of a pivotal Phase…
Altimmune announced update on AdCOVIDï¾™ phase 1 clinical trial
On Jun. 29, 2021, Altimmune announced phase 1 AdCOVID clinical trial data that showed AdCOVID appeared to be…
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…
Biden Administration invested $3 billion from American Rescue Plan as part of COVID-19 antiviral development strategy
On Jun. 17, 2021, the Biden Administration is investing more than $3 billion to accelerate the discovery, development…
Relief Therapeutics reported that NRx Pharma announced additional results from Aviptadil expanded access protocol for patients with COVID-19
On Jun. 16, 2021, RELIEF THERAPEUTICS reported that its collaboration partner, NRx Pharmaceuticals, had announced additional results from…
KPWHRI announced volunteers needed for COVID-19 vaccine-booster trial
On Jun. 16, 2021, Kaiser Permanente Washington Health Research Institute (KPWHRI) announced that was recruiting volunteers in the…
Oncotelic closes COVID-19 clinical trial early
On Jun. 15, 2021, Oncotelic announced that, as of June 11, 2021, it discontinued enrollment in its OT-101…
Humanigen initiated submission for lenzilumab Marketing Authorization in COVID-19, to United Kingdomï¾’s MHRA
On Jun. 14, 2021 Humanigen announced it had initiated a rolling review submission for Marketing Authorization (MA) by…
Merck announced supply agreement with U.S. Government for molnupiravir, an Investigational oral antiviral treatment of COVID-19
On Jun. 8, 2021, Merck announced it had entered into a procurement agreement with the U.S. government for…
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,…
NIH clinical trial evaluating mixed COVID-19 vaccine schedules began
On Jun. 1, 2021, the National Institutes of Health announced that it had started a Phase 1/2 clinical…
Biotechnology | Diagnostics | Disease | FDA | Life Science News | 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…