Drugs in the Pipeline
Phase 3 Trial Update of OMS302 for Intraocular Lens Replacement Surgery
Omeros reported positive data from its Phase 3 clinical trial evaluating OMS302 in patients undergoing intraocular lens replacement surgery.
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Drugs in the Pipeline
Eliquis sNDA Accepted for Review for DVT Prophylaxis
The FDA has accepted Bristol-Myers Squibb's and Pfizer's supplemental New Drug Application for Eliquis (apixaban), an oral direct Factor Xa inhibitor for prophylaxis of deep vein thrombosis (DVT) following hip or knee replacement surgery.
Drugs in the Pipeline
OMS302 NDA Submitted for Intraocular Lens Replacement Surgery
A New Drug Application for OMS302, a combination of phenylephrine and ketorolac has been submitted to the FDA by Omeros for patients undergoing intraocular lens replacement surgery.
Drugs in the Pipeline
Oliceridine Being Investigated as Possible IV Opioid Analgesic Replacement
The Food and Drug Administration (FDA) has granted Fast Track designation to oliceridine (TRV130; Trevena) for the management of moderate-to-severe acute pain.
Drugs in the Pipeline
Phase 3 Study of NPSP558 for Hypoparathyroidism in Adults
NPS Pharmaceuticals announced positive results from its Phase 3 REPLACE study of NPSP558 for the treatment of hypoparathyroidism in adults.
Drugs in the Pipeline
Gene Therapy Candidate Fast Tracked for GM1 Gangliosidosis
LYS-GM101 is a gene therapy designed to replace the gene mutation and restore the production of the beta-galactosidase enzyme.
Drugs in the Pipeline
Rare Neurologic Disorder Therapy Granted Orphan Drug Status
The Food and Drug Administration (FDA) has granted Orphan Drug designation to its investigational therapy RE-024 (phosphopantothenate replacement therapy; Retrophin), for the treatment of pantothenate kinase-associated neurodegeneration (PKAN).
Drugs in the Pipeline
Second Phase 3 Study of OMS302 for Intraocular Lens Replacement Surgery
Omeros announced that patient enrollment has begun for its second Phase 3 trial for OMS302 in intraocular lens replacement (ILR) surgery.
Drugs in the Pipeline
FDA to Review Natpara BLA for Hypoparathyroidism
The FDA has accepted for review NPS Pharmaceuticals' Biologics License Application (BLA) for Natpara (recombinant human parathyroid hormone 1-84, rhPTH[1-84]) for the treatment of hypoparathyroidism.
Drugs in the Pipeline
First-In-Class Enzyme Replacement Therapy for Hypophosphatasia Under Review
The FDA has accepted for Priority Review the Biologics License Application (BLA) for asfotase alfa in the treatment of patients with infantile-and juvenile-onset hypophosphatasia (HPP).
