News
Drug ApprovalAcquisitionBreakthrough Therapy
Lexicon Pharmaceuticals Announces Submission of Additional Data to U.S. FDA Supporting the Benefit-Risk Profile of Zynquista® in Type 1 Diabetes
NDA
Moleculin Doses First EU Patient in Phase 3 Pivotal MIRACLE Trial for Treatment of Acute Myeloid Leukemia
Orphan DrugFast TrackClinical Study
Theratechnologies Announces Availability of EGRIFTA WR™ (tesamorelin) for injection to Reduce Excess Abdominal Fat in Adults with HIV and Lipodystrophy
Drug Approval
ImmunotherapyFast Track
Junshi Biosciences Announces the Phase 3 Study of JS005 (IL-17A) for the Treatment of Moderate to Severe Plaque Psoriasis Met Primary Endpoints
Clinical ResultDrug Approval
Mineralys Therapeutics Presents Subgroup Analyses of Phase 3 Launch-HTN Trial Demonstrating Efficacy and Safety of Lorundrostat in Hypertension Participants with High Unmet Medical Need
Clinical ResultNDAAHA
Palisade Bio Receives Health Canada Clearance for Phase 1b Trial of PALI-2108 in Fibrostenotic Crohn’s Disease (FSCD)
IND
uniQure Announces Initial AMT-191 Phase I/IIa Data Showing Sustained Increases in α-Gal A Enzyme Activity in Patients with Fabry Disease
Clinical ResultOrphan DrugGene TherapyFast TrackClinical Study