News about Quality / GMP

Concord Biotech Successfully Completes ANVISA Inspection at Limbasi API Manufacturing Facility

Concord Biotech has successfully completed an ANVISA inspection at its Limbasi Active Pharmaceutical Ingredient (API) manufacturing facility, strengthening its regulatory standing and expansion into Brazil's pharmaceutical market.

Quality / GMP | 12/06/2026 | By News Bureau |  159

Lupin Receives US FDA Approval for Interchangeable Biosimilar Ranibizumab, Ranluspec

Lupin has secured US FDA approval for Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar to Lucentis, expanding its biosimilars portfolio and broadening access to treatments for retinal and vision-related disorders.

Quality / GMP | 05/06/2026 | By News Bureau |  166

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 |  222

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 |  121

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 |  163

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 |  134

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 |  148

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 |  120

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 |  268

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 |  114