FDA Approves Neuren Pharmaceutical’s Phase II Trial of NNZ-2591 for Prader-Willi Syndrome
The FDA has approved Neuren Pharmaceuticals' Phase 2 clinical trial for its NNZ-2591 drug for children with Prader-Willi syndrome, a neurological disorder with no approved treatment options. The trial ...
DualityBio’s DB-1303 Granted Fast-Track Status by FDA for Advanced Endometrial Cancer Treatment
Duality Biologics has announced that the FDA has granted Fast Track Designation to DB-1303, a novel antibody-drug conjugate, for the treatment of advanced, recurrent or metastatic endometrial carcinom ...
FDA Approves TUKYSA® for Metastatic HER2-Positive Colorectal Cancer
Seagen Inc. announced FDA accelerated approval of TUKYSA for RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer. It's the first FDA-approved treatment for HER2-positive metastat ...
FDA Grants Priority Review for OPNT003 Nasal Nalmefene to Treat Opioid Overdose
The FDA has accepted for Priority Review the New Drug Application for Opiant Pharmaceutical's OPNT003, an intranasal formulation containing the high-affinity opioid antagonist nalmefene, for the treat ...
First Patient Enrolled in Phase 3 Trial of Abelacimab for High-Risk Atrial Fibrillation Patients
Anthos Therapeutics has enrolled the first patient in a Phase 3 study to evaluate the efficacy and safety of abelacimab in high-risk patients with atrial fibrillation deemed unsuitable for current ant ...
Evaxion has received FDA approval to move forward with a Phase 2b clinical study for EVX-01
Evaxion Biotech A/S, a clinical-stage biotech company, announced that the FDA had given the green light for their Phase 2b clinical trial of EVX-01. The Company submitted an IND and Fast Track applica ...
Legend Biotech Announces Acceptance of Ciltacabtagene Autoleucel (Cilta-Cel) NDA in China
Legend Biotech Corp. announced that China's National Medical Products Administration accepted its New Drug Application for ciltacabtagene autoleucel, a novel therapy to treat life-threatening diseases ...