What AGC Biologics’ role in Waskyra tells us about the future of ethical cell therapy scale-up
Waskyra’s FDA and EMA approvals spotlight AGC Biologics’ rare disease manufacturing model. Find out what this means for future nonprofit-led therapies.
Pharma & Biotech
Pharma & Biotech
Can epcoritamab reshape salvage DLBCL care? Genmab’s Phase 3 data brings regulatory momentum
Genmab’s epcoritamab improved PFS in a Phase 3 DLBCL trial. Find out how this could reshape bispecific monotherapy in aggressive B-cell lymphoma care.
Pharma & Biotech
Elunetirom shows synaptogenic promise as Autobahn eyes pivotal trials in depression
Autobahn’s elunetirom may offer a novel neuroplasticity-driven treatment for depression. Find out what its latest data mean for the future of MDD therapy.
Pharma & Biotech
FDA grants orphan drug designation to Atossa’s (Z)-Endoxifen for Duchenne: What’s next?
Atossa Therapeutics Inc. has received Orphan Drug Designation from the U.S. Food and Drug Administration for its investigational compound (Z)-Endoxifen in the treatment of Duchenne muscular dystrophy (DMD). The designation, disclosed on January 16, 2026, supplements the previously granted Rare Pediatric Disease Designation for the same compound and indication. The move marks a notable regulatory
Pharma & Biotech
Saudi FDA approves ImmunityBio’s ANKTIVA in NSCLC: What this means for immunotherapy 2.0
Find out how ImmunityBio’s subcutaneous immunotherapy ANKTIVA secured Saudi approval for NSCLC and what it means for global immuno-oncology.
Pharma & Biotech
Allergy relief shake-up: Dr. Reddy’s launches generic Pataday 0.7% eye drops
Dr. Reddy’s launches first U.S. generic of Pataday 0.7% eye drops. Find out what this means for the OTC allergy market and Novartis’s branded edge.
Medical Devices & Diagnostics
Can wearable ultrasound reinvent breast imaging? What the iSono Health ATUSA launch really signals
iSono Health launches ATUSA™, the first wearable breast ultrasound. Find out how it could transform access, accuracy, and economics in breast imaging.
Medical Devices & Diagnostics
FDA clears BEAR Implant label for lower osteoarthritis risk: What this changes in ACL surgery
FDA clears PTOA risk reduction claim for Miach Orthopaedics’ BEAR Implant. Find out what this means for ACL treatment, patients, and future adoption.
Medical Devices & Diagnostics
FDA clears VizMark’s VM1 tumor marker: Is this the fix for MRI artifact in breast imaging?
VizMark’s VM1 marker receives FDA clearance for artifact-free breast imaging. Find out how this may change tumor localization in dense breast cases.
Medical Devices & Diagnostics
What FDA breakthrough status for the Amplifi Vein Dilation System means for dialysis care in 2026
Amplifi Vascular's device earns FDA Breakthrough and CMS Category B status. Find out what this means for dialysis access innovation and payer alignment.