United States Food and Drug Administration
Roche Advances Alzheimer’s Disease Diagnosis with Breakthrough Blood Test
Alzheimer’s disease, blood test, Roche, Eli Lilly, FDA breakthrough device designation, pTau217, amyloid pathology, early diagnosis.
Novartis Secures First-Line Approval for Scemblix in Newly Diagnosed Chronic Myeloid Leukemia Patients
Scemblix, Novartis, first-line approval, chronic myeloid leukemia, CML, newly diagnosed, FDA approval
FDA Advisory Committee Votes Against Zynquista for Type 1 Diabetes and Chronic Kidney Disease, Despite Support for Subgroup Benefits
FDA Advisory Committee, Zynquista (sotagliflozin), Type 1 Diabetes (T1D), Chronic Kidney Disease (CKD), Glycemic Control, SGLT1/SGLT2 Inhibitor, Lexicon Pharmaceuticals
FDA Announces Availability of All Doses of Novo Nordisk’s Ozempic and Wegovy
FDA, Novo Nordisk, Ozempic, Wegovy, drug shortage, semaglutide, obesity treatment, type 2 diabetes treatment
TCT 2024: Johnson & Johnson’s Abiomed Successfully Completes Pivotal Study for Innovative Shrinkable Heart Pump, Impella ECP
TCT 2024, Johnson & Johnson, Abiomed, Impella ECP, Shrinkable Heart Pump, High-Risk PCI, Cardiogenic Shock, FDA Approval
Lexicon’s Diabetes Drug Zynquista Faces FDA Scrutiny Again Ahead of Advisory Committee Meeting
Lexicon Pharmaceuticals, Zynquista, FDA, diabetes drug, advisory committee, regulatory challenges
Biogen and Sage Discontinue Plans for Major Depressive Disorder Approval for 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
Novartis, Scemblix, FDA Approval, First-Line Treatment, CML, Chronic Myeloid Leukemia, ASC4FIRST Trial, Tyrosine Kinase Inhibitors, STAMP Inhibitor
Biopharma Industry Alarmed by Prospect of RFK Jr. Shaping FDA Policies Under Trump Administration
RFK Jr., FDA, Trump Administration, Biopharma, Healthcare Policy, Agriculture Policy
FDA Approves Protega’s 10 mg Abuse-Deterrent Opioid Roxybond for Pain Management
FDA approval, Protega Pharmaceuticals, Roxybond, abuse-deterrent opioid, pain management, SentryBond technology