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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 | 281
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 | 176
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 | 114
Replicate Bioscience has been awarded a USD 3 million grant from the Gates Foundation to advance the development of self-replicating RNA-based tuberculosis vaccines, expanding its efforts to combat major infectious diseases including TB, HIV, malaria and rabies.
Quality / GMP | 20/06/2026 | By News Bureau | 149
Chugai Files Regulatory Application in Japan for IgA Nephropathy Drug Sparsentan
Chugai Pharmaceutical has applied for regulatory approval in Japan for sparsentan, a dual-action oral therapy for IgA nephropathy. Clinical studies showed significant reductions in proteinuria and potential benefits in preserving kidney function, offering hope for patients with limited treatment options.
Quality / GMP | 20/06/2026 | By News Bureau | 237
Allergan Aesthetics Secures FDA Approval for Skinvive by Juvederm to Treat Neck Wrinkles
Allergan Aesthetics, an AbbVie company, has received US FDA approval for Skinvive by Juvéderm to reduce neck wrinkles and improve overall neck appearance.
Quality / GMP | 18/06/2026 | By News Bureau | 107
WuXi Biologics Secures 4th EMA GMP Certification for Suzhou Facility
WuXi Biologics’ Suzhou Biosafety Testing Center has received its 4th EMA GMP certification, supporting European Union (EU) Marketing Authorisation (MA) applications for 19 biologics from 13 stakeholders.
Quality / GMP | 18/06/2026 | By News Bureau | 111
Alembic Pharma Receives US FDA Approval for Generic Tretinoin Cream
Alembic Pharmaceuticals has secured final USFDA approval for its generic Tretinoin Cream USP, 0.05 percent, used in the treatment of acne vulgaris, targeting a US market estimated at USD 76 million.
Quality / GMP | 16/06/2026 | By News Bureau | 213
Bayer Secures US FDA Approval for Ambelvist, a Low-Dose MRI Contrast Agent
Bayer’s Ambelvist (gadoquatrane) has received US FDA approval for contrast-enhanced MRI in adults and children, offering effective lesion visualization while reducing gadolinium exposure through a low-dose formulation.
Quality / GMP | 16/06/2026 | By News Bureau | 117
AstraZeneca's Ultomiris Granted FDA Priority Review for Rare Kidney Disease IgAN
The US FDA has granted Priority Review to AstraZeneca’s supplemental application for Ultomiris in immunoglobulin A nephropathy, bringing the therapy closer to becoming the first C5 complement inhibitor approved for the rare kidney disease.
Quality / GMP | 16/06/2026 | By News Bureau | 179
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