Performance
FDA Pushes for Onshoring and Improved Data Fidelity in Generic Drug User Fee (GDUFA IV) Negotiations
FDA; onshoring; data fidelity; generic drugs; user fee; GDUFA IV; manufacturing; bioequivalence; public health; performance metrics
Maximizing ROI with Educational Content for Healthcare Marketers: 2025 Trends and Strategies
healthcare marketing; educational content; ROI; patient engagement; data analytics; AI personalization; point-of-care (POC) marketing; digital strategies; market differentiation; content performance metrics
Cytokinetics Stock Soars After Positive Phase 3 Data as FDA Approval Decision for Aficamten Nears
Cytokinetics; Aficamten; FDA approval; Phase 3 trial; obstructive hypertrophic cardiomyopathy (oHCM); PDUFA date; REMS; stock performance
Elevidys Sales Surge in Sarepta Q2 2025 Despite Safety Concerns
Sarepta Therapeutics; Elevidys; Q2 2025; gene therapy; sales performance; FDA; safety issues; shipment pause
Leap Therapeutics’ Stock Plummets Following Disappointing DKK1 Antibody Results in Gastric Cancer Trials
Leap Therapeutics, DKK1 Antibody, Gastric Cancer, Clinical Trials, Stock Performance
Q32 Bio Inc. Faces Market Volatility After Bempikibart Program Update
Q32 Bio Inc., bempikibart, autoimmune diseases, IL-7/TSLP pathways, stock performance, market volatility
Pyxis Oncology Faces Setback as Early ADC Readout in Solid Tumors Fails to Impress
Pyxis Oncology, ADC, PYX-201, solid tumors, clinical trial, stock performance
Icon, Irish CRO Giant, Announces Layoffs Following Disappointing Q3 Performance
Icon, layoffs, Q3 performance, Irish CRO, biotech industry
Novo Nordisk’s Wegovy Sales Shortfall: A Rare Setback for the Danish Drugmaker
Novo Nordisk, Wegovy, weight-loss drug, sales shortfall, stock performance, pharmaceutical industry
Novel Monthly Hemophilia A Treatment by Novos Poses Challenge to Roche’s Hemlibra
Hemophilia A, Novos, Roche, Hemlibra, monthly treatment, performance, challenge.