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Akums Launches DCGI-Approved Triple-Action Therapy for Diabetic Neuropathic Pain
Akums Drugs & Pharmaceuticals has introduced a DCGI-approved triple-action capsule that combines pregabalin, methylcobalamin and delayed-release duloxetine to offer comprehensive management of diabetic peripheral neuropathic pain while supporting nerve regeneration.
Quality / GMP | 01/07/2026 | By News Bureau | 107
Artivion Secures US FDA Approval for AMDS Hybrid Prosthesis to Treat Acute Aortic Dissections
Artivion has received US FDA approval for its AMDS Hybrid Prosthesis, enabling broader adoption of the aortic arch remodelling device that has demonstrated significant reductions in mortality and major complications for patients with acute DeBakey Type I aortic dissections.
Quality / GMP | 01/07/2026 | By News Bureau
Roche's Enspryng Receives FDA Priority Review for Thyroid Eye Disease
Roche's Enspryng has received FDA Priority Review for thyroid eye disease after Phase 3 studies demonstrated clinically meaningful improvements in eye bulging, disease activity and double vision, with a regulatory decision expected by October 2026.
Quality / GMP | 01/07/2026 | By News Bureau
Nuvation Bio's Taletrectinib Advances UK Regulatory Review for ROS1-Positive Lung Cancer
The UK's MHRA has validated the marketing application for Nuvation Bio's taletrectinib, bringing the next-generation ROS1 inhibitor one step closer to approval for patients with advanced ROS1-positive non-small cell lung cancer in the UK.
Quality / GMP | 01/07/2026 | By News Bureau
US FDA approves Viridian's Lumvoa for treatment of thyroid eye disease
Viridian Therapeutics secures US FDA approval for Lumvoa, the first IGF-1R antagonist approved to treat both active and chronic thyroid eye disease, with commercial launch set to begin immediately.
Quality / GMP | 30/06/2026 | By News Bureau
Jubilant Generics Receives USFDA Tentative Approval for Pantoprazole Sodium Oral Suspension
FDA’s tentative approval strengthens Jubilant Generics' US product pipeline and positions the company to launch Pantoprazole Sodium Delayed Release Oral Suspension following patent expiry later this year.
Quality / GMP | 30/06/2026 | By News Bureau
EMA Recommends Approval of Datroway for First-Line Treatment of Triple-Negative Breast Cancer
AstraZeneca and Daiichi Sankyo have received a positive recommendation from the European Medicines Agency's CHMP for Datroway as a first-line treatment for unresectable or metastatic triple-negative breast cancer in patients who are not eligible for immunotherapy, supported by Phase 3 trial results demonstrating improved survival and disease control.
Quality / GMP | 29/06/2026 | By News Bureau
US FDA Approves Pfizer's Ibrance for Maintenance Treatment of HR+, HER2+ Metastatic Breast Cancer
FDA approval makes Ibrance the first CDK4/6 inhibitor indicated for HR+ metastatic breast cancer regardless of HER2 status.
Quality / GMP | 26/06/2026 | By News Bureau | 244
Hikma Welcomes FDA Approval of Guardant360 Liquid CDx, Expanding Precision Cancer Diagnostics
The FDA-approved Guardant360 Liquid CDx enables advanced cancer biomarker testing through a simple blood draw, supporting faster and more precise treatment decisions.
Quality / GMP | 25/06/2026 | By News Bureau
The European Commission has approved Padcev in combination with Keytruda as the first perioperative treatment for cisplatin-ineligible patients with resectable muscle-invasive bladder cancer in Europe.
Quality / GMP | 25/06/2026 | By News Bureau
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