Qualitative Concept – Page 47

Vertex’s CASGEVY Marks Historic Milestone with First Commercial Patient Infusions, Paving the Way for 2025 Launches

10 months ago talkbio0Tagged Anemia, Sickle Cell, Approved, Casgevy, commercial, CRISPR/Cas9, gene therapy, Infusion procedures, launches, United States Food and Drug Administration

CASGEVY, Vertex Pharmaceuticals, gene therapy, sickle cell disease, beta thalassemia, CRISPR/Cas9, FDA approval, commercial patient infusions, 2025 launches.

FDA Raises Sterility and Quality Concerns at Mark Cuban’s Dallas Drug Compounding Facility

10 months ago talkbio0Tagged concerns, Cost Plus, Cuban, Dallas, Dallas facility, Infertility, Massive, Quality, United States Food and Drug Administration

Mark Cuban, Cost Plus Drugs, FDA, sterility concerns, quality issues, drug compounding, Dallas facility

Journey Medical’s Emrosi Receives FDA Approval, Setting New Standard for Rosacea Treatment

10 months ago talkbio0Tagged Approved, dermatological conditions, Emrosi, hydrochloride, Journey, minocycline, New Standard of Care, Rosacea, United States Food and Drug Administration

Rosacea treatment, Emrosi, FDA approval, Minocycline hydrochloride, Journey Medical Corporation, Dermatological conditions, New standard of care

Novartis Secures First-Line Approval for Scemblix in Newly Diagnosed Chronic Myeloid Leukemia Patients

11 months ago talkbio0Tagged Approved, Diagnosis, First-Line Approval, Myeloid Leukemia, Chronic, Novartis, Scemblix, United States Food and Drug Administration

Scemblix, Novartis, first-line approval, chronic myeloid leukemia, CML, newly diagnosed, FDA approval

Compass Pathways Delays Phase 3 Psilocybin Trials, Cuts 30% of Workforce to Conserve Cash

11 months ago talkbio0Tagged Cash, Compass Pathways, Conservation, Phase 3, psilocybin trials, psychedelic drug development

Compass Pathways, psilocybin trials, Phase 3 delays, workforce reduction, cash conservation, psychedelic drug development

FDA Announces Availability of All Doses of Novo Nordisk’s Ozempic and Wegovy

11 months ago talkbio0Tagged Diabetes, Drug Shortage, Nordisk, Obesity, semaglutide, United States Food and Drug Administration, Wegovy

FDA, Novo Nordisk, Ozempic, Wegovy, drug shortage, semaglutide, obesity treatment, type 2 diabetes treatment

Blue Earth Therapeutics Advances with $76.5M Series A Financing for Next-Gen Radiohybrid RLTs

11 months ago talkbio0Tagged Blue color, cellular targeting, financing characteristics, Greek letter alpha (qualifier value), lutetium, Phase II studies, RLTs

Blue Earth Therapeutics, Series A financing, radiohybrid RLTs, Phase II studies, targeted therapies, lutetium, alpha emitter.

TCT 2024: Johnson & Johnson’s Abiomed Successfully Completes Pivotal Study for Innovative Shrinkable Heart Pump, Impella ECP

11 months ago talkbio0Tagged Abiomed, Approved, High-Risk PCI, Impella, Johnson & Johnson, RNASE3 gene, Shock, Cardiogenic, Shrinkable Heart Pump, Thrombin Time Assay, United States Food and Drug Administration

TCT 2024, Johnson & Johnson, Abiomed, Impella ECP, Shrinkable Heart Pump, High-Risk PCI, Cardiogenic Shock, FDA Approval

Biogen and Sage Discontinue Plans for Major Depressive Disorder Approval for Zurzuvae

11 months ago talkbio0Tagged Approved, Biogen, Depression, Postpartum, Depressive disorder, United States Food and Drug Administration, Zurzuvae

Biogen, Sage Therapeutics, Zurzuvae, postpartum depression, major depressive disorder, FDA approval

Novartis Secures FDA Approval for Scemblix as First-Line Treatment for Newly Diagnosed CML, Anticipates $3B in Peak Sales

11 months ago talkbio0Tagged Approved, first-line, Inhibitor, Myeloid Leukemia, Chronic, Novartis, Scemblix, TTLL5 gene, Tyrosine Kinase Inhibitors [MoA], United States Food and Drug Administration

Novartis, Scemblix, FDA Approval, First-Line Treatment, CML, Chronic Myeloid Leukemia, ASC4FIRST Trial, Tyrosine Kinase Inhibitors, STAMP Inhibitor