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fda

A collection of 28 Posts

Senhwa Biosciences' CX-5461 Receives FDA IND Clearance for MYC-Driven Lymphoma Trial, Eyes Pan-Cancer Potential post image
regulatory fda clinical-trials

Senhwa Biosciences' CX-5461 Receives FDA IND Clearance for MYC-Driven Lymphoma Trial, Eyes Pan-Cancer Potential

by Newsdesk
First Covid Pill That Prevents Infection After Exposure Awaits FDA Approval post image
regulatory fda clinical-trials

First Covid Pill That Prevents Infection After Exposure Awaits FDA Approval

by Newsdesk
First Covid Pill That Prevents Infection After Exposure Awaits FDA Approval post image
regulatory fda clinical-trials

First Covid Pill That Prevents Infection After Exposure Awaits FDA Approval

by Newsdesk
Clinical trial leads to FDA approval of drug for rare, deadly blood cancer post image
regulatory fda clinical-trials

Clinical trial leads to FDA approval of drug for rare, deadly blood cancer

by Newsdesk
D3 Bio, Inc. Announces FDA Breakthrough Therapy Designation and Orphan Drug Designation for D3S-001 for the Treatment of Patients with KRAS G12C-Mutated Cancers post image
regulatory fda clinical-trials

D3 Bio, Inc. Announces FDA Breakthrough Therapy Designation and Orphan Drug Designation for D3S-001 for the Treatment of Patients with KRAS G12C-Mutated Cancers

by Newsdesk
Celcuity to Initiate NDA Submission of Gedatolisib in PIK3CA Wild-Type Cohort in HR+/HER2- Advanced Breast Cancer Under FDA’s Real-Time Oncology Review Program post image
regulatory fda clinical-trials

Celcuity to Initiate NDA Submission of Gedatolisib in PIK3CA Wild-Type Cohort in HR+/HER2- Advanced Breast Cancer Under FDA’s Real-Time Oncology Review Program

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
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