Today, GSK plc (LSE/NYSE: GSK) has announced that the US Food and Drug Administration (FDA) has extended the review period of the New Drug Application (NDA) for momelotinib by an additional three months to allow for the evaluation of newly submitted data. The revised completion date is now set for 16th September 2023. Despite this […]
Zantac Recall Expands, New Options help PV patients calm Itching
MPN Patients have multiple Over The Counter options to relieve Itching! by Jennifer Acker For many PV patients the combination of Zantac (an H2 blocker) and Zyrtec (an H1 blocker) have been effective in providing relief from pruritus, a severe itching condition that is a common MPN symptom. PV Reporter first uncovered this impressive treatment […]
Geron Granted Fast Track Designation on Imetelstat for MF
Geron Announces Fast Track Designation Granted to Imetelstat for Relapsed/Refractory Myelofibrosis MENLO PARK, Calif., Sept. 30, 2019 (GLOBE NEWSWIRE) — Geron Corporation (Nasdaq: GERN) today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to imetelstat for the treatment of adult patients with Intermediate-2 or High-risk myelofibrosis (MF) whose […]
Inrebic (Fedratinib) receives FDA Approval for Myelofibrosis
The First New Treatment in Nearly a Decade for MF Patients INREBIC provides new, once-daily oral option for patients affected by rare bone marrow cancer SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ: CELG) today announced the U.S. Food and Drug Administration (FDA) has approved INREBIC® (fedratinib) for the treatment of adult patients with intermediate-2 or high-risk primary or […]
Celgene’s Fedratinib Given FDA Priority Review for New Drug Application in Myelofibrosis
PV Reporter was first to break the news on the Expanded Access Program for Fedratinib for Myelofibrosis Patients on November 16th, 2018. The next logical step for Celgene was filing for New Drug Application – Granted by the FDA on March 5th, 2019 Celgene Corporation announced today the U.S. Food and Drug Administration has accepted […]
