Approved
FDA Approves Expanded Use of VTAMA and Nemluvio for Atopic Dermatitis Treatment
FDA approval, atopic dermatitis, VTAMA, Nemluvio, Galderma, Organon, dermatology, skin conditions
FDA Approves UNLOXCYT for Advanced Cutaneous Squamous Cell Carcinoma, Marking a New Era in Skin Cancer Treatment
UNLOXCYT, cosibelimab-ipdl, FDA approval, advanced cutaneous squamous cell carcinoma (cSCC), checkpoint inhibitor, immunotherapy, skin cancer treatment.
Candel Therapeutics Sees Dramatic Stock Surge Following Successful Phase III Prostate Cancer Trial
Candel Therapeutics, CAN-2409, Phase III trial, prostate cancer, viral immunotherapy, stock surge, FDA approval
uniQure Secures FDA Agreement on Accelerated Approval Pathway for Huntington’s Disease Gene Therapy AMT-130
uniQure, FDA, Accelerated Approval, Huntington’s Disease, Gene Therapy, AMT-130, cUHDRS, Neurofilament Light Chain (NfL), Regenerative Medicine Advanced Therapy (RMAT)
Novo Holdings Receives Unconditional EU Approval for $16.5 Billion Acquisition of Catalent
Novo Holdings, Catalent, European Commission, Acquisition, EU Approval, Pharmaceutical Services
FDA Grants Accelerated Approval to Merus’ Bizengri for NRG1+ Lung and Pancreatic Cancers
Bizengri, NRG1+ cancers, FDA accelerated approval, lung cancer, pancreatic cancer, zenocutuzumab-zbco, Merus N.V.
FDA Approves Imfinzi for Limited-Stage Small Cell Lung Cancer, Marking First Systemic Immunotherapy for LS-SCLC
Imfinzi (durvalumab), Limited-stage small cell lung cancer (LS-SCLC), FDA approval, Systemic immunotherapy, ADRIATIC Phase III trial, Breakthrough Therapy Designation, Priority Review
Biocon Biologics Secures FDA Approval for YESINTEK, a Biosimilar to Stelara
Biocon Biologics, FDA approval, YESINTEK, Stelara biosimilar, ustekinumab, inflammatory diseases
Outlook Therapeutics to Resubmit BLA for ONS-5010 Despite Missing Primary Endpoint in NORSE EIGHT Trial
Outlook Therapeutics, ONS-5010, Lytenava, Wet Age-Related Macular Degeneration (wet AMD), Biologics License Application (BLA), NORSE EIGHT Trial, FDA Approval
FDA Approves BridgeBio’s Attruby for ATTR-CM, Offering New Hope for Patients
Attruby, BridgeBio, ATTR-CM, FDA approval, transthyretin amyloid cardiomyopathy, acoramidis, TTR stabilizer