How OrganaBio’s RxMP partnership could advance RMP-402 for severe bleeding control
Find out how OrganaBio’s RxMP partnership could advance RMP-402, a first-in-class therapy for severe bleeding control.
Acadia Pharmaceuticals broadens Rett syndrome treatment flexibility with DAYBUE STIX rollout in the United States
Acadia Pharmaceuticals has launched DAYBUE STIX for Rett syndrome in the U.S. Read what this means for adoption, tolerability, and market strategy.
Why CTIS is betting FDA’s E2B(R3) deadline will reshape pharmacovigilance software demand;
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 high-stakes test in the U.S. idiopathic pulmonary fibrosis market
Cipla’s nintedanib approval opens a new chapter in U.S. idiopathic pulmonary fibrosis care. Read what it changes for pricing, access, and competition.
Can Drug Farm turn ALPK1 inhibition into the first real disease-modifying approach for ROSAH syndrome?
Drug Farm won FDA orphan drug designation for DF-003 in ROSAH syndrome. Read what this rare disease milestone could change next.
Ferring wins ADSTILADRIN label update as operational efficiency becomes a bigger oncology battleground
FDA clears faster ADSTILADRIN thawing for bladder cancer care. Read why this workflow update could matter for NMIBC adoption and treatment strategy.
How Glenmark Pharmaceuticals’ fluticasone inhaler approval could reshape the U.S. asthma inhaler market
Glenmark Pharmaceuticals wins FDA approval for generic fluticasone inhaler with 180-day exclusivity. Read what it means for the U.S. asthma drug market.
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.
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 […]
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.