Category Regulatory

Coya Therapeutics

Coya Therapeutics Reports Positive Interim Results of IL-2 and CTLA4-Ig Combination in Mild to Moderate Frontotemporal Dementia

Coya Therapeutics Reports Positive Interim Results of IL-2 and CTLA4-Ig Combination in Mild to Moderate Frontotemporal Dementia Coya Therapeutics, Inc. , a clinical-stage biotechnology company specializing in the development of biologic therapies designed to enhance the function of regulatory T…

Read MoreCoya Therapeutics Reports Positive Interim Results of IL-2 and CTLA4-Ig Combination in Mild to Moderate Frontotemporal Dementia
ADSTILADRIN

FDA Approves Second Manufacturing Facility for ADSTILADRIN (nadofaragene firadenovec-vncg)

FDA Approves Second Manufacturing Facility for ADSTILADRIN (nadofaragene firadenovec-vncg) In a significant development for the biopharmaceutical industry, Ferring Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) for a state-of-the-art manufacturing hub dedicated to the production of…

Read MoreFDA Approves Second Manufacturing Facility for ADSTILADRIN (nadofaragene firadenovec-vncg)
Approval

Novocure’s Optune Lua Earns CE Mark Approval for Treating Metastatic Non-Small Cell Lung Cancer

Novocure’s Optune Lua® Earns CE Mark Approval for Treating Metastatic Non-Small Cell Lung Cancer In a significant development for the treatment of advanced lung cancer, Novocure announced that its innovative device, Optune Lua®, has received the Conformité Européenne (CE) Mark,…

Read MoreNovocure’s Optune Lua Earns CE Mark Approval for Treating Metastatic Non-Small Cell Lung Cancer
Verastem

Verastem Gets U.S. IND Clearance for KRAS G12D Inhibitor VS-7375, Paving Way for Phase 1/2a Trial in Solid Tumors

Verastem Gets U.S. IND Clearance for KRAS G12D Inhibitor VS-7375, Paving Way for Phase 1/2a Trial in Solid Tumors Verastem Oncology (Nasdaq: VSTM), a Boston-based biopharmaceutical company at the forefront of developing precision oncology therapies, has announced a significant milestone…

Read MoreVerastem Gets U.S. IND Clearance for KRAS G12D Inhibitor VS-7375, Paving Way for Phase 1/2a Trial in Solid Tumors
FDA

FDA Grants Breakthrough Status to BrainChild Bio’s CAR T Therapy for Pediatric Brain Tumors

FDA Grants Breakthrough Status to BrainChild Bio’s CAR T Therapy for Pediatric Brain Tumors BrainChild Bio, Inc., a clinical-stage biotechnology company at the forefront of neuro-oncology cell therapy innovation, has achieved a significant regulatory milestone with the announcement that its…

Read MoreFDA Grants Breakthrough Status to BrainChild Bio’s CAR T Therapy for Pediatric Brain Tumors
eGenesis

eGenesis and OrganOx Secure U.S. FDA IND Clearance for Acute-On-Chronic Liver Failure Treatment

eGenesis and OrganOx Secure U.S. FDA IND Clearance for Acute-On-Chronic Liver Failure Treatment eGenesis, a pioneering biotechnology company focused on developing human-compatible engineered organs, and OrganOx Ltd., a leading medical technology company specializing in organ preservation and support systems, today…

Read MoreeGenesis and OrganOx Secure U.S. FDA IND Clearance for Acute-On-Chronic Liver Failure Treatment
ImmunityBio

ImmunityBio Files Supplemental BLA for NMIBC and Expands ANKTIVA Access for Lymphopenia Treatment

ImmunityBio Files Supplemental BLA for NMIBC and Expands ANKTIVA Access for Lymphopenia Treatment ImmunityBio, Inc. (NASDAQ: IBRX), a leading company specializing in immunotherapy, has recently made significant strides in advancing its therapeutic offerings. The company announced the completion of multiple…

Read MoreImmunityBio Files Supplemental BLA for NMIBC and Expands ANKTIVA Access for Lymphopenia Treatment