News about Quality / GMP

HUTCHMED Gets Priority Review in China for Fanregratinib NDA

HUTCHMED’s NDA for fanregratinib in second-line intrahepatic cholangiocarcinoma has been accepted in China with priority review status, supported by data from a phase II registration trial addressing a high-unmet-need liver cancer indication.

Quality / GMP | 02/01/2026 | By News Bureau

EMA Grants Accelerated Assessment to WCK 5222 by Wockhardt

The European Medicines Agency (EMA) has granted Accelerated Assessment status to Wockhardt’s WCK 5222, a fixed-dose combination of zidebactam and cefepime, following a pre-submission meeting—potentially enabling a faster regulatory review of the novel antibiotic therapy.

Quality / GMP | 02/01/2026 | By News Bureau

Outlook Therapeutics Updates FDA Review of ONS-5010/LYTENAVA for Wet AMD

Outlook Therapeutics has provided an update on the U.S. Food and Drug Administration’s review of its resubmitted Biologics License Application (BLA) for ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration, following the FDA’s issuance of a Complete Response Letter (CRL).

Quality / GMP | 01/01/2026 | By News Bureau

FDA Accepts for Review INOVIO BLA for INO-3107 in RRP

The US FDA has accepted for review INOVIO’s Biologics Licence Application (BLA) for INO-3107 for the treatment of adults with Recurrent Respiratory Apillomatosis (RRA), assigning a PDUFA action date of 30 October, 2026, and indicating that it does not currently plan to convene an advisory committee meeting for the application.

Quality / GMP | 31/12/2025 | By News Bureau

Vanda Pharma Wins FDA Approval for NEREUS to Prevent Motion Induced Vomiting

Vanda Pharmaceuticals has received FDA approval for NEREUS (tradipitant) to prevent motion-induced vomiting, marking the first new pharmacologic treatment for motion sickness in more than four decades and a significant advance in managing a condition that affects a large segment of the population and impacts military operational readiness.

Quality / GMP | 31/12/2025 | By News Bureau

Tiziana Submits Annual Safety Report for Intranasal Foralumab to FDA

Tiziana has submitted its annual safety report for intranasal foralumab to the US FDA, reporting an excellent safety profile based on 37.4 cumulative patient-years of exposure and highlighting the continued need for safer therapies following the FDA’s denial of Sanofi’s tolebrutinib for non-relapsing secondary progressive multiple sclerosis.

Quality / GMP | 30/12/2025 | By News Bureau

IPC to Conduct 36th Pharmacovigilance Skill Development Programme in March 2026

The Indian Pharmacopoeia Commission (IPC), the National Coordination Centre (NCC) for the Pharmacovigilance Programme of India (PvPI), will organise the 36th Skill Development Programme (SDP) on Pharmacovigilance (PV) from March 9 to March 13, 2026. The programme will be conducted in online mode.

Quality / GMP | 29/12/2025 | By Darshana

Innovent TABOSUN Becomes China's First Approved Domestic Anti CTLA 4 Antibody

Innovent Biologics has received approval from China’s National Medical Products Administration (NMPA) for TABOSUN (Ipilimumab N01 Injection), marking the country’s first domestically developed anti-CTLA-4 monoclonal antibody and a significant milestone in China’s immuno-oncology landscape.

Quality / GMP | 26/12/2025 | By News Bureau

US FDA Approves Agios' AQVESME for Thalassemia-Related Anaemia

The US FDA has approved Agios’ AQVESME for the treatment of anaemia in adults with thalassemia, making it the only approved therapy for both transfusion-dependent and non-transfusion-dependent patients. The drug will be marketed in the US under the AQVESME brand for thalassemia, with availability expected in late January 2026.

Quality / GMP | 24/12/2025 | By News Bureau

GC Biopharma Wins IND Approval in Korea for Phase I COVID-19 mRNA Vaccine Trial

GC Biopharma has received IND approval in Korea to initiate a Phase I clinical trial of its COVID-19 mRNA vaccine, marking a key step in advancing its mRNA platform, with plans to submit a Phase II IND in the second half of 2026.

Quality / GMP | 24/12/2025 | By News Bureau