Lykos Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for MDMA-Assisted Therapy for PTSD
Lykos Therapeutics (formerly MAPS Public Benefit Corporation) (“Lykos”), a company dedicated to transforming mental healthcare, announced that the U.S. Food and Drug Administration (“FDA”) has accepted its new drug application (“NDA”) for midomafetamine capsules (“MDMA”) used in combination with psychological intervention,…
NRx Pharmaceuticals (Nasdaq: NRXP) to Present Keynote Address on Ketamine Efficacy and Risks at Upcoming Sachs Neuroscience Innovation Forum in San Francisco
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals”, (NRx), a clinical-stage biopharmaceutical company today announced that it has been selected to give the keynote address entitled “Ketamine for Suicidal Depression: The Benefits are Clear, But So are the Risks,” at the upcoming…
NRx Pharmaceuticals Announces Signing of a Data and Technical Information Agreement with Columbia University Accessing Key Data Demonstrating Efficacy and Safety of Intravenous Ketamine for the Treatment of Suicidal Depression
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals”, the “Company”), a clinical-stage biopharmaceutical company, today announced that it has signed a License Data and Technical Information Agreement with Columbia University for rights to data from a randomized, active-controlled trial of 80 patients hospitalized for…
Johnson & Johnson Submits Supplemental Biologics License Application and New Drug Application to U.S. FDA Seeking Approval of RYBREVANT® (amivantamab-vmjw) Plus Lazertinib for the Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC)
Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) together with a New Drug Application (NDA) seeking the approval of RYBREVANT® (amivantamab-vmjw) in combination with lazertinib for the…
RedHill and U.S. Army Announce Opaganib and RHB-107 Combinations with Remdesivir Show Distinct Synergistic Effect Against Ebola
Investigational drugs opaganib and RHB-107 (upamostat) demonstrate distinct synergistic effect when combined individually with remdesivir, significantly improving potency while maintaining cell viability, in a new U.S. Army-funded and conducted in vitro Ebola virus study Opaganib and RHB-107 are both novel,…
New Drug Application of Mabwell’s 8MW0511 for Injection Accepted by NMPA
Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that the new drug application of its recombinant (yeast-secreted) human serum albumin-human granulocyte colony-stimulating factor (I) fusion protein for injection (R&D code: 8MW0511) has been accepted by the National…
NRx Pharmaceuticals and Nephron Pharmaceuticals Announce Joint Agreement to Develop Intravenous Ketamine to Treat Suicidal Depression
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals”, (NRx), a clinical-stage biopharmaceutical company and Nephron Pharmaceuticals, Inc. (Nephron), a leading manufacturer of sterile injectable drugs today announced the signing of a development and manufacturing agreement to manufacture a presentation of ketamine suitable…
Henlius’ Novel Anti-PD-1 mAb HANSIZHUANG (Serplulimab) Approved for the Treatment of ESCC
Shanghai Henlius Biotech, Inc. (2696. HK) announced that the new drug application (NDA) for new indication of HANSIZHUANG (serplulimab injection), an innovative anti-PD-1 monoclonal antibody independently developed by the company, in combination with drugs containing fluorouracil and platinum for the…
