United States Food and Drug Administration
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
FDA Rejects Applied Therapeutics’ Rare Disease Drug Govorestat, Citing Clinical Application Deficiencies
Applied Therapeutics, FDA rejection, govorestat, galactosemia, rare metabolic disease, clinical application deficiencies
Biocon Biologics Secures FDA Approval for YESINTEK, a Biosimilar to Stelara
Biocon Biologics, FDA approval, YESINTEK, Stelara biosimilar, ustekinumab, inflammatory diseases
FDA Rejects Govorestat for Classic Galactosemia, Citing Clinical Deficiencies
FDA rejection, govorestat, classic galactosemia, Applied Therapeutics, rare disease drug approval, clinical deficiencies
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
Outlook Therapeutics Stock Crashes Following Clinical Trial Failure for Wet AMD Therapy
Outlook Therapeutics, OTLK, stock price, clinical trial failure, wet AMD therapy, ONS-5010, FDA filing
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
Axsome Therapeutics Narcolepsy Drug AXS-12 Achieves Phase III Success, Paving Way for US FDA Filing
Axsome Therapeutics, AXS-12, narcolepsy, Phase III trial, ENCORE trial, FDA filing, NDA
Incyte Unveils Promising Monjuvi Data at ASH24, Paving Way for FDA Label Expansion in Follicular Lymphoma
Incyte, Monjuvi, ASH24, Follicular Lymphoma, Label Expansion, FDA, Phase 3 Trial