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Humanigen’s Partner in South Korea Receives Ministry of Food and Drug Safety (MFDS) Approval to Conduct Phase 1 Study of Lenzilumab
7/22/2021
Humanigen, Inc. have received approval from South Korea’s MFDS (the South Korean equivalent of the U.S. FDA) to conduct a Phase 1 clinical study of lenzilumab, which may support potential use in the treatment of hospitalized COVID-19 patients.
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UK’s MHRA accepts Humanigen’s submission of Lenzilumab for Marketing Authorization in COVID-19 for expedited rolling review
7/9/2021
Humanigen, Inc., announced its submission for Marketing Authorization for lenzilumab in COVID-19, begun in June 2021, has been accepted by the United Kingdom’s Medicines and Healthcare Products Regulatory Agency for expedited COVID-related rolling review, with assessment expected to occur more rapidly than a standard rolling review.
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Cancer Immunotherapy Sales to Continue Surging through 2031 amid Rising Cases of Cancer and its Relapse: Fact MR
7/7/2021
The Fact.MR survey on cancer immunotherapy market offers detailed analysis on the key growth drivers and trends affecting demand in the market.
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Humanigen Inc. Added to Russell 3000(R) Index
6/28/2021
The event represents the ongoing accomplishments of Humanigen during a transformational year in developing lenzilumab for the treatment of newly hospitalized patients with COVID-19, and its intentions to continue to develop lenzilumab for the treatment of CAR-T, GvHD, and CMML.
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Findings from the study suggest the oral JAK inhibitor tofacitinib could be a potential contender in the race to identify benefits for COVID-19 in already approved therapies.
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Humanigen Initiates Submission for Lenzilumab Marketing Authorization in COVID-19, to the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA)
6/14/2021
Humanigen, Inc., a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’, announced it has initiated a rolling review submission for Marketing Authorization by the MHRA for its lead drug candidate, lenzilumab.
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Humanigen Announces Ken Trbovich Appointed as Senior Vice President, Investor Relations
6/7/2021
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, today announced the appointment of Ken Trbovich to the newly-created role of SVP of Investor Relations
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Humanigen to Present at the 2021 LD Micro Invitational XI
6/3/2021
Humanigen, Inc. (Nasdaq: HGEN), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, today announced it will present at the 2021 LD Micro Invitational XI, held virtually from June 8- 10, 2021.
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Humanigen Submits Application to FDA for Emergency Use Authorization for Lenzilumab in COVID-19
5/28/2021
Humanigen, Inc. (Nasdaq:HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, today announced that the company submitted an application to the US Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for lenzilumab for the treatment of patients hospitalized with COVID-19.
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GM-CSF Gene-Edited CAR-T Data to be Presented at International Society for Cell & Gene Therapy Annual Meeting 2021
5/26/2021
Humanigen, Inc. (Nasdaq: HGEN), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab™, today announced that granulocyte macrophage-colony stimulating factor (GM-CSF) gene-edited CAR-T data will be presented at the International Society for Cell & Gene Therapy (ISCT) 2021 Annual Meeting
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Approvals and Commercialization of Biopharmaceutical Drugs Driving Global Anti-Inflammatory Cytokines Market: Fact MR
5/26/2021
Emergence of effective and more targeted anti-inflammatory biologics drugs for the treatment of anti-inflammatory cytokines assists the overall expansion of the market
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Qualigen Therapeutics, Inc. Appoints Tariq Arshad, MD, MBA as Chief Medical Officer
5/19/2021
Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a biotechnology company focused on developing novel therapeutics for the treatment of cancer and viral diseases, today announced the appointment of Tariq Arshad, MD, MBA to the newly-created position of Senior Vice President, Chief Medical Officer.
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Humanigen to Present at Jefferies Healthcare Conference
5/19/2021
Humanigen, Inc . (Nasdaq: HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab™, today announced that the Company’s management team will participate in a fireside chat at the Jefferies Healthcare Conference being held from June 1-4, 2021.
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COVID-19 News: Test for Asymptomatic People, Bemcentinib in Hospitalized COVID-19 Patients and More
5/18/2021
Please check out the biopharma industry's COVID-19 stories that are trending for May 18, 2021. -
Humanigen and Chime Biologics Enter Into Manufacturing Agreement for COVID-19 Therapeutic Candidate Lenzilumab
5/17/2021
Humanigen, Inc. today announced that they have entered into a manufacturing services agreement to produce lenzilumab bulk drug substance and drug product for Humanigen for commercial sale following receipt of the requisite regulatory authorizations or approvals in regions outside of the United States including Europe, the United Kingdom, India and Brazil.
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Humanigen reported it had held a meeting with the FDA to discuss plans for filing an EUA for its lenzilumab for hospitalized, hypoxic COVID-19 patients by the end of May.
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Humanigen Reports First Quarter 2021 Financial Results
5/13/2021
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab™, today reported financial results for the first quarter ending March 31, 2021 and provided a regulatory update on lenzilumab.
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EVERSANA advances commercialization readiness as Humanigen announces publication of phase 3 randomized double-blind placebo-controlled study demonstrating the efficacy and safety of lenzilumab™ in newly hospitalized COVID-19 patients
5/6/2021
EVERSANA, a pioneer of next generation services to the global life sciences industry, today congratulated its partner, Humanigen, on the publication of positive results from the lenzilumab LIVE-AIR Phase 3 study in newly hospitalized COVID-19 patients.
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Humanigen Announces Publication of Results From Phase 3 Randomized Double-Blind Placebo-Controlled Study Demonstrating the Efficacy and Safety of Lenzilumab™ in Hospitalized COVID-19 Patients
5/5/2021
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, announced that results from the lenzilumab Phase 3 study in hospitalized COVID-19 patients (referred to as ‘LIVE-AIR’) were published online at link .