Idea or Concept
Roche’s Phase III Trial Success with IL-6 Blocker Enspryng Tempered by Modest Outcomes
Roche, IL-6 blocker, Enspryng (satralizumab), Phase III trial, Generalized Myasthenia Gravis (gMG), Disappointment, Expectations
MacroGenics and AbbVie Discontinue Development of ADAM9 Antibody-Drug Conjugate (IMGC936)
MacroGenics, AbbVie, Partnered ADC, ADAM9, IMGC936, Early Data, Safety Concerns, Efficacy Issues
Brukinsa Broadens Horizons: FDA Clears Follicular Lymphoma Combination Therapy
Brukinsa, Follicular lymphoma, FDA approval, BTK inhibitor, BTK inhibitor, Broadest label, Relapsed or refractory follicular lymphoma, ROSEWOOD Phase II study, CHMP positive opinion, Obinutuzumab combination therapy, Accelerated approval, Relapsed or refractory follicular lymphoma, Relapsed or refractory marginal zone lymphoma, Chronic lymphoma, CHMP recommendation, Phase II ROSEWOOD trial, Overall response rate (OR
Boundless Bio, Oncology Startup Targeting Extrachromosomal DNA, Files for $100 Million IPO
Boundless Bio, Oncology Startup, Initial Public Offering (IPO), Extrachromosomal DNA (ecDNA), Small Molecule Drugs (ecDTx), Checkpoint Kinase 1 Inhibitors, Phase 1 Trials, Nasdaq Listing (Symbol: BOLD), Backed by Bayer and Arch Venture Partners, Preliminary Data Expected in Second Half of 2024
Minerva’s Roluperidone for Schizophrenia Symptoms Denied Approval by FDA
United States Food and Drug Administration, MFSD1 gene, Symptoms aspect, Schizophrenia, New Drug Application
New York Attorney General Demands Enhanced Safety Labeling for Pediatric Use of Singulair
Singulair, United States Food and Drug Administration, Pediatric brand name, Child, Lawyer (occupation)
Minerva Entangles in Web of FDA Rejection Again Over Schizophrenia Drug Roluperidone
United States Food and Drug Administration, MFSD1 gene, Schizophrenia
Venatorx Confident in Quick Resolution of Manufacturing Concerns for Cefepime-Taniborbactum Antibiotic Despite FDA Setback
United States Food and Drug Administration, Venatorx, CID, 2024-02-23, cefepime-taniborbactam, Manufacture
ViiV’s Long-Acting Cabenuva Outperforms Daily Oral Therapy in Phase III Study
cabenuva, Daily, Standard of Care, Adherence (attribute), HIV, Participant, daily
Eicos Sciences’ Aurlumyn: First FDA-Approved Treatment for Severe Frostbite Reduces Amputation Risk
Aurlumyn, Eicos, Amputation, Sciences’, iloprost, severe frostbite