new drug application

Lykos Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for MDMA-Assisted Therapy for PTSD

2 min read

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...

NRx Pharmaceuticals (Nasdaq: NRXP) to Present Keynote Address on Ketamine Efficacy and Risks at Upcoming Sachs Neuroscience Innovation Forum in San Francisco

NRx Pharmaceuticals Keynote - "Ketamine for Suicidal Depression"

2 min read

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...

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

2 min read

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...

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)

2 min read

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....

RedHill and U.S. Army Announce Opaganib and RHB-107 Combinations with Remdesivir Show Distinct Synergistic Effect Against Ebola

3 min read

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...

New Drug Application of Mabwell’s 8MW0511 for Injection Accepted by NMPA

2 min read

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...

NRx Pharmaceuticals and Nephron Pharmaceuticals Announce Joint Agreement to Develop Intravenous Ketamine to Treat Suicidal Depression

2 min read

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...

Henlius’ Novel Anti-PD-1 mAb HANSIZHUANG (Serplulimab) Approved for the Treatment of ESCC

2 min read

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...

new drug application

Lykos Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for MDMA-Assisted Therapy for PTSD

NRx Pharmaceuticals (Nasdaq: NRXP) to Present Keynote Address on Ketamine Efficacy and Risks at Upcoming Sachs Neuroscience Innovation Forum in San Francisco

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

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)

RedHill and U.S. Army Announce Opaganib and RHB-107 Combinations with Remdesivir Show Distinct Synergistic Effect Against Ebola

New Drug Application of Mabwell’s 8MW0511 for Injection Accepted by NMPA

NRx Pharmaceuticals and Nephron Pharmaceuticals Announce Joint Agreement to Develop Intravenous Ketamine to Treat Suicidal Depression

Henlius’ Novel Anti-PD-1 mAb HANSIZHUANG (Serplulimab) Approved for the Treatment of ESCC

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