Browsing Tag
FDA
316 posts
AstraZeneca, Daiichi Sankyo secure FDA approval for Enhertu in two early breast cancer indications
Enhertu is moving from late-stage control to early-stage cure. AstraZeneca and Daiichi Sankyo now face the bigger test: adoption.
Anteris Technologies (ASX: AVR) stock up 9.6% as PARADIGM trial reaches first US patient enrolments
Edwards and Medtronic own TAVR. Anteris (ASX: AVR) wants in with DurAVR. First US PARADIGM patients enrolled, US$320m raised, and Medtronic is now a shareholder.
4DMedical (ASX: 4DX) stock up 7.3% as Mayo Clinic adoption and GSK contract reset lung imaging story
Nuclear medicine VQ scans are a US$1 billion market. 4DMedical (ASX: 4DX) just landed Mayo Clinic, GSK, and Medicare. The question is now scan volume scaling speed.
What the Acclaim cochlear implant’s pivotal data could mean for the broader hearing device market
Could Envoy Medical, Inc.’s Acclaim implant reshape the hearing-device market? Explore the regulatory, commercial, and industry implications.
Image Analysis Group and HeartcoR Solutions target clinical trial bottlenecks with integrated core lab model
Clinical trials have too many data silos. IAG and HeartcoR Solutions are betting integrated core labs can cut friction for sponsors.
Mirum Pharmaceuticals (NASDAQ: MIRM) jumps 13% after VISTAS Phase 2b PSC win
Two Phase 2b wins in seven days. A pre-NDA meeting this summer. Mirum is starting to look less like a single-product rare disease story.
Is setmelanotide the first true disease-targeted therapy for hypothalamic obesity?
Is setmelanotide redefining hypothalamic obesity treatment? Explore what Rhythm Pharmaceuticals, Inc.’s EU approval means for markets and growth.
Can the BACKBEAT trial validate a new category of device-driven hypertension therapy?
What does the BACKBEAT trial mean for Medtronic plc and Orchestra BioMed Holdings, Inc.? Discover the future of device-driven hypertension therapy.
Cataract surgery’s hidden battleground: How OVDs became strategic for Alcon, BLCO and JNJ
Cataract surgery is exploding globally. The gel that keeps the eye open during it has become a strategic battleground for Alcon, BLCO and JNJ.
GSK trades near 2,027p as Q1 core EPS rises 9%, full-year 2026 guidance reaffirmed
GSK beat the top line and held guidance, but the harder question is whether Specialty Medicines can keep outrunning the Vaccines and General Medicines drag.