HeartBeam Receives FDA Setback on ECG Software Application
HeartBeam receives NSE letter from FDA for 12-Lead ECG software but plans alternative product launch with already-cleared 3D ECG system.
HeartBeam receives NSE letter from FDA for 12-Lead ECG software but plans alternative product launch with already-cleared 3D ECG system.
Sangamo Therapeutics receives FDA approval to submit rolling application for ST-920, a one-time gene therapy treating Fabry disease, with accelerated review pathway granted.
GSK subsidiary Tesaro and AnaptysBio file dueling lawsuits in Delaware court over alleged breaches of their 2014 Jemperli licensing agreement, with trial set for July 2026.
Mizuho initiates coverage on Tarsus Pharmaceuticals with an Outperform rating and a $100 price target, citing strong prospects for Xdemvy and projected peak sales above $2B.
Cantor Fitzgerald initiates coverage of Lexeo Therapeutics with an Overweight rating, praising its cardiac gene therapy programs and transparent updates.
Nuvation Bio shares jump 49% Wed. after strong Ibtrozi results and analyst upgrades, signaling growth potential in biotech and cancer treatments.