News about Global Pharma

Emiltatug Ledadotin Wins FDA Breakthrough Tag for Adenoid Cystic Carcinoma

Emiltatug Ledadotin receives U.S. Food and Drug Administration Breakthrough Therapy designation for adenoid cystic carcinoma, a potentially innovative and differentiated Antibody Drug Conjugate (ADC) directed against B7-H4, a well-characterised target in certain cancers including ACC.

Global Pharma | 13/05/2026 | By News Bureau |  200

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 |  167

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 |  249

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 |  378

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 |  265

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 |  330

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 |  318

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 |  242

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 |  161

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 |  325