News about Quality / GMP

Alvotech Gets FDA Approval for Second AVT02 Manufacturing Suite

Alvotech receives FDA approval to manufacture AVT02 drug substance in its second Reykjavik production suite.

Quality / GMP | 06/10/2026 | By News Bureau

US FDA Inspection of Unichem's Goa Facility Ends With 5 Observations

US FDA conducted a six-day inspection at Unichem Laboratories’ Goa formulation facility, concluding with five observations related to procedural enhancements.

Quality / GMP | 30/09/2026 | By News Bureau

Envoy Medical Expands Global IP Portfolio to 97 Patents

Envoy Medical secures two additional international patents, taking its global granted patent portfolio to 97 across the US and foreign markets.

Quality / GMP | 24/09/2026 | By News Bureau

FDA Updates Winrevair Label With Phase 3 HYPERION Data

Merck’s Winrevair label has been updated by the US FDA to include data from the Phase 3 HYPERION trial in recently diagnosed adults with pulmonary arterial hypertension.

Quality / GMP | 23/09/2026 | By News Bureau |  109

Anixa Biosciences Secures Australian Patent for Breast Cancer Vaccine

Anixa Biosciences receives an Australian patent for its breast cancer vaccine technology, expanding its global intellectual property portfolio.

Quality / GMP | 22/09/2026 | By News Bureau |  105

FDA Grants Priority Review to Insmed's Arikayce sNDA

Insmed’s Arikayce sNDA receives FDA Priority Review for the treatment of MAC lung disease, with a PDUFA target action date of January 28, 2027.

Quality / GMP | 22/09/2026 | By News Bureau

Japan Approves Merck's Keytruda Qlex for Subcutaneous Use

Merck’s Keytruda Qlex receives MHLW approval in Japan for subcutaneous use across all locally approved Keytruda indications.

Quality / GMP | 22/09/2026 | By News Bureau

Concord Biotech Gujarat Plant Gets One US FDA Observation

Concord Biotech’s formulation facility in Gujarat has completed a US FDA inspection with one minor procedural observation, according to the company.

Quality / GMP | 19/09/2026 | By News Bureau |  108

Merck Gets Positive EU Opinion for Keytruda-Padcev in MIBC

Merck’s Keytruda plus Padcev receives a positive CHMP opinion for perioperative treatment of adults with resectable muscle-invasive bladder cancer, with the EC set to review the recommendation.

Quality / GMP | 19/09/2026 | By News Bureau

US FDA Grants Fast Track Designation to OncoC4's Cesalatamig

US FDA grants Fast Track Designation to OncoC4’s cesalatamig for patients with NSCLC whose disease has progressed following PD-(L)1-targeted immunotherapy and platinum-based chemotherapy.

Quality / GMP | 17/09/2026 | By News Bureau