Acadia Pharmaceuticals has launched DAYBUE STIX for Rett syndrome in the U.S. Read what this means for adoption, tolerability, and market strategy.
CTIS launches Trial SafetyXchange to help pharma firms meet the FDA E2B(R3) deadline. Read what it changes for safety reporting teams.
Cipla’s nintedanib approval opens a new chapter in U.S. idiopathic pulmonary fibrosis care. Read what it changes for pricing, access, and competition.
Drug Farm won FDA orphan drug designation for DF-003 in ROSAH syndrome. Read what this rare disease milestone could change next.
FDA clears faster ADSTILADRIN thawing for bladder cancer care. Read why this workflow update could matter for NMIBC adoption and treatment strategy.
Glenmark Pharmaceuticals wins FDA approval for generic fluticasone inhaler with 180-day exclusivity. Read what it means for the U.S. asthma drug market.
ViroMissile expands its IDOV-Immune Phase I trial to U.S. sites after FDA IND clearance. Discover what this means for systemic oncolytic therapy.
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 […]
Novartis gains FDA orphan status for iptacopan in myasthenia gravis. Explore how this oral complement inhibitor could challenge biologics in neurology.
FDA approves subcutaneous Lunsumio VELO for relapsed follicular lymphoma. Explore what this changes for bispecific antibodies and outpatient cancer care.