FDA IND clearance propels ViroMissile’s IDOV-Immune into major U.S. cancer centers
ViroMissile expands its IDOV-Immune Phase I trial to U.S. sites after FDA IND clearance. Discover what this means for systemic oncolytic therapy.
Pharma & Biotech
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
Oral complement therapy for myasthenia gravis? Novartis’ iptacopan enters the neurology arena
Novartis gains FDA orphan status for iptacopan in myasthenia gravis. Explore how this oral complement inhibitor could challenge biologics in neurology.
Pharma & Biotech
What Genentech’s Lunsumio VELO approval means for relapsed follicular lymphoma treatment
FDA approves subcutaneous Lunsumio VELO for relapsed follicular lymphoma. Explore what this changes for bispecific antibodies and outpatient cancer care.
Pharma & Biotech
Hansa Biopharma files BLA for imlifidase in kidney transplant desensitization: What this changes for U.S. patients
Hansa Biopharma files for FDA approval of imlifidase to enable kidney transplants in highly sensitized patients. Find out what changes next.