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regulatory

A collection of 57 Posts

Innovent Biologics Announces U.S. FDA IND Approval for the First Global MRCT Phase 3 Study (MarsLight-11) of IBI363 (PD-1/IL-2α-bias) in Squamous Non-Small Cell Lung Cancer post image
regulatory fda clinical-trials

Innovent Biologics Announces U.S. FDA IND Approval for the First Global MRCT Phase 3 Study (MarsLight-11) of IBI363 (PD-1/IL-2α-bias) in Squamous Non-Small Cell Lung Cancer

by Newsdesk
COVID-19 "Vaccine Alternative" Based On Monoclonal Antibodies May Be On A Fast-Track To FDA Approval post image
regulatory fda clinical-trials

COVID-19 "Vaccine Alternative" Based On Monoclonal Antibodies May Be On A Fast-Track To FDA Approval

by Newsdesk
Novel Gene Therapy for ALS cleared for global trials in China and the U.S. post image
regulatory fda clinical-trials

Novel Gene Therapy for ALS cleared for global trials in China and the U.S.

by Newsdesk
Invivyd Aligns with U.S. FDA on Rapid Pathway to Full Approval (BLA) of Vaccine Alternative Monoclonal Antibody VYD2311 to Protect American Adults and Adolescents from COVID-19 post image
regulatory fda clinical-trials

Invivyd Aligns with U.S. FDA on Rapid Pathway to Full Approval (BLA) of Vaccine Alternative Monoclonal Antibody VYD2311 to Protect American Adults and Adolescents from COVID-19

by Newsdesk
FDA Shift In Drug Approvals Halts Trial Of Second Skin Cancer Drug post image
regulatory fda clinical-trials

FDA Shift In Drug Approvals Halts Trial Of Second Skin Cancer Drug

by Newsdesk
Innovent Biologics Announces U.S. FDA IND Approval for the First Global MRCT Phase 3 Study (MarsLight-11) of IBI363 (PD-1/IL-2α-bias) in Squamous Non-Small Cell Lung Cancer post image
regulatory fda clinical-trials

Innovent Biologics Announces U.S. FDA IND Approval for the First Global MRCT Phase 3 Study (MarsLight-11) of IBI363 (PD-1/IL-2α-bias) in Squamous Non-Small Cell Lung Cancer

by Newsdesk
Invivyd Aligns with U.S. FDA on Rapid Pathway to Full Approval (BLA) of Vaccine Alternative Monoclonal Antibody VYD2311 to Protect American Adults and Adolescents from COVID-19 post image
regulatory fda clinical-trials

Invivyd Aligns with U.S. FDA on Rapid Pathway to Full Approval (BLA) of Vaccine Alternative Monoclonal Antibody VYD2311 to Protect American Adults and Adolescents from COVID-19

by Newsdesk
Orchestra BioMed Reports Second Quarter 2025 Financial Results and Highlights Recent Business Updates post image
regulatory fda clinical-trials

Orchestra BioMed Reports Second Quarter 2025 Financial Results and Highlights Recent Business Updates

by Newsdesk
Lilly's New Pill: A Weight Loss Game-Changer? post image
regulatory fda clinical-trials

Lilly's New Pill: A Weight Loss Game-Changer?

by Newsdesk