News about Quality / GMP

FDA Expands Approval of Agilent's PD-L1 Diagnostic Test on Dako Omnis Platform for Four Additional Cancer Types

Agilent Technologies has received FDA approval to expand the use of its PD-L1 IHC 22C3 pharmDx test on the Dako Omnis platform, broadening access to PD-L1 testing for four additional tumour types and supporting streamlined pathology laboratory operations.

Quality / GMP | 05/06/2026 | By News Bureau |  179

Lupin and Natco Secure USFDA Approval for Generic Cancer Drug Eribulin Mesylate Injection

Lupin and Natco Pharma have received USFDA approval for Eribulin Mesylate Injection, a generic equivalent of Halaven, used in the treatment of advanced breast cancer and liposarcoma.

Quality / GMP | 03/06/2026 | By News Bureau

US FDA Approves TREMFYA Label Update for Inhibition of Joint Damage Progression in Psoriatic Arthritis

Johnson & Johnson’s IL-23 inhibitor becomes the first in its class to include evidence of structural joint damage inhibition in adults with active psoriatic arthritis.

Quality / GMP | 30/05/2026 | By News Bureau |  127

Abbott Secures CE Mark for World's First Dual Glucose and Ketone Monitoring System for Diabetes Management

Abbott has received CE Mark approval for Libre Duo, the world’s first dual glucose-ketone sensing technology, offering continuous monitoring of both glucose and ketone levels to help prevent diabetic ketoacidosis and support safer diabetes care.

Quality / GMP | 30/05/2026 | By News Bureau |  120

Antengene Corporation receives CDE endorsement to begin pivotal phase 3 CLINCH-3 study of ATG-022

Antengene has received approval from China’s Center for Drug Evaluation to initiate the pivotal Phase 3 CLINCH-3 study of ATG-022, advancing the development of its innovative antibody-drug conjugate for CLDN18.2-positive gastric cancers.

Quality / GMP | 30/05/2026 | By News Bureau |  112

WHO Recommends Doxycycline Post-Exposure Prophylaxis to Prevent Bacterial STIs in High-Risk Populations

The World Health Organisation has issued its first recommendation on doxycycline Post-Exposure Prophylaxis (doxyPEP) for preventing bacterial STI, marking a significant step towards expanding evidence-based STI prevention options for vulnerable populations.

Quality / GMP | 30/05/2026 | By News Bureau |  107

Travere Therapeutics Receives USPTO Patent Allowance for Filspari Use in IgA Nephropathy

Travere Therapeutics has secured a Notice of Allowance from the USPTO for a patent application covering specific methods of using Filspari (sparsentan) in the treatment of IgA nephropathy, strengthening its rare kidney disease portfolio.

Quality / GMP | 29/05/2026 | By News Bureau |  202

Aphios Corporation Secures US Patent Allowance for Novel Bryoid Therapeutics Targeting Neurodegenerative Diseases and Cancer

Aphios Corporation has received a Notice of Allowance from the USPTO for a divisional patent application covering novel Bryoid compositions and manufacturing methods aimed at advancing therapies for neurodegenerative diseases, HIV latency and cancer.

Quality / GMP | 29/05/2026 | By News Bureau

FDA Grants Priority Review to Sanofi's Venglustat for Type 3 Gaucher Disease

Sanofi’s brain-penetrant investigational therapy venglustat has received FDA priority review after phase 3 data demonstrated positive efficacy and safety outcomes in patients with type 3 Gaucher disease.

Quality / GMP | 29/05/2026 | By News Bureau |  109

GSK Reports Positive Phase 3 Results for Bepirovirsen in Chronic Hepatitis B Treatment

GSK’s investigational antisense oligonucleotide bepirovirsen demonstrated statistically significant functional cure rates in chronic hepatitis B patients, offering a potential alternative to lifelong antiviral therapy.

Quality / GMP | 29/05/2026 | By News Bureau |  229