News about Quality / GMP

Atossa Therapeutics Receives FDA Go-Ahead for (Z)-Endoxifen IND in Metastatic Breast Cancer

Atossa Therapeutics announced that it has received a “Study May Proceed” letter from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for (Z)-endoxifen in metastatic breast cancer, clearing the way for the initiation of clinical studies evaluating the therapy.

Quality / GMP | 07/01/2026 | By News Bureau |  373

Ascletis Receives FDA IND Clearance for Phase II ASC30 Diabetes Study

Ascletis has received US FDA IND clearance to initiate a 13-week phase-II, randomised, double-blind, placebo-controlled, multi-centre study evaluating the efficacy, safety and tolerability of its oral small-molecule GLP-1 candidate ASC30 in participants with diabetes, with enrollment expected to begin in the first quarter of 2026.

Quality / GMP | 05/01/2026 | By News Bureau |  218

ScinoPharm Wins FDA Approval for Glatiramer Acetate Injection

ScinoPharm Taiwan has received US FDA approval for its Glatiramer Acetate Injection for the treatment of multiple sclerosis, marking a significant milestone as the first and only Taiwanese pharmaceutical company to secure FDA approval for this complex generic, and reinforcing Taiwan’s growing role in the global pharmaceutical supply chain.

Quality / GMP | 05/01/2026 | By News Bureau |  233

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 |  149

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 |  437

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 |  236

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 |  310

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 |  363

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 |  280

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 |  451