News about Global Pharma

Onco-Innovations Subsidiary Partners with GSK on Real-World Oncology Data Research

Inka Health and GSK will collaborate to develop real-world data methodologies aimed at improving the applicability of oncology clinical trial findings across diverse patient populations and healthcare settings.

Global Pharma | 07/05/2026 | By News Bureau

Cellenkos Receives US FDA IND Clearance for CK0802 Phase 1b/ 2a Trial in GVHD

The US Food and Drug Administration (FDA) clears Cellenkos Inc IND for CK0802, a first-in-class off-the-shelf Treg therapy, advancing to a phase 1b/2a trial in steroid-refractory Graft-Versus-Host Disease (GVHD).

Global Pharma | 06/05/2026 | By News Bureau

Incyte Wins US FDA Approval for Jakafi XR (Ruxolitinib)

The US Food and Drug Administration (FDA) approves Incyte Corporation’s Jakafi XR (ruxolitinib), a once-daily extended-release tablet for myelofibrosis, polycythemia vera and GVHD, offering consistent day-long exposure.

Global Pharma | 02/05/2026 | By News Bureau |  118

Arrowhead Pharmaceuticals Wins Australia TGA Approval for REDEMPLO

Arrowhead Pharmaceuticals receives TGA approval for REDEMPLO (plozasiran) in Australia, the first treatment for Familial Chylomicronemia Syndrome (FCS), backed by phase 3 data showing significant triglyceride reduction and lower pancreatitis risk.

Global Pharma | 01/05/2026 | By News Bureau |  105

China's Center of Drug Evaluation Accepts Marketing Authorisation Application for Bayer's FXIa Inhibitor

Center for Drug Evaluation accepts Bayer’s marketing authorisation application for FXIa inhibitor asundexian in stroke prevention, supported by phase 3 OCEANIC-STROKE data.

Global Pharma | 30/04/2026 | By News Bureau |  135

Pfizer Reaches Three Settlement Deals for VYNDAMAX

Pfizer reaches three settlement agreements for VYNDAMAX, extending US patent exclusivity to June 1, 2031, subject to the outcome of other litigation.

Global Pharma | 30/04/2026 | By News Bureau

US FDA Approves Regeneron's Otarmeni, First Gene Therapy for Genetic Hearing Loss

US Food and Drug Administration (FDA) approves Regeneron’s Otarmeni, the first AAV-based gene therapy, offering a potential treatment for severe-to-profound hearing loss.

Global Pharma | 27/04/2026 | By News Bureau

AbbVie Provides US Regulatory Update on TrenibotE BLA

AbbVie gets US FDA Complete Response Letter (CRL) for TrenibotE BLA tied to manufacturing processes; no new clinical studies needed.

Global Pharma | 24/04/2026 | By News Bureau

Integrated DNA Technologies Expands Manufacturing Capacity to Boost Cancer Research Solutions

Integrated DNA Technologies expands its Coralville facility, tripling production capacity to support faster, scalable solutions for cancer research and next-generation sequencing applications.

Global Pharma | 22/04/2026 | By News Bureau |  140

Syntegon Posts Record Year in 2025 and Aims for Further Growth

Syntegon reports a record 2025 with revenue up 10 percent to €1.75 billion and pharma sales surging 22 percent, alongside strong EBITDA and cash flow growth, reinforcing its position as a key lifecycle partner for pharma, biotech and food industries.

Global Pharma | 21/04/2026 | By News Bureau |  135