News about Quality / GMP

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 |  545

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 |  293

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 |  296

EU Approves Sanofi's Wayrilz as First BTK Inhibitor for Immune Thrombocytopenia

Sanofi has received EU approval for Wayrilz, the first Bruton’s Tyrosine Kinase (BTK) inhibitor indicated for immune thrombocytopenia, offering a novel multi-immune modulation approach. The approval is based on positive results from LUNA 3 study, which demonstrated rapid and durable platelet responses.

Quality / GMP | 24/12/2025 | By News Bureau |  290

Bayer Secures Japanese Approval for Finerenone

Bayer has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Finerenone (Kerendia), a non-steroidal, selective mineralocorticoid receptor antagonist, for the treatment of adult patients with chronic heart failure with mildly reduced or preserved Left Ventricular Ejection Fraction (LVEF).

Quality / GMP | 23/12/2025 | By News Bureau |  599

Amneal Gains US FDA Approval for Prolia and XGEVA Denosumab Biosimilars

The US FDA approvals for Prolia and XGEVA denosumab biosimilars strengthen Amneal’s growing biosimilars portfolio, with the company planning to commercialise six biosimilars across eight presentations by 2027.

Quality / GMP | 23/12/2025 | By News Bureau |  319

US FDA Approves Wegovy by Novo Nordisk as first Oral GLP-1 for Weight Loss

Wegovy’s approval is supported by phase III OASIS 4 trial data showing a mean weight loss of 16.6 percent, with the oral GLP-1 indicated for long-term weight management and reduction of major adverse cardiovascular events, and Novo Nordisk planning a US launch in early January 2026.

Quality / GMP | 23/12/2025 | By News Bureau |  435

Enhertu Secures US BTD Status in Early HER2-Positive Breast Cancer

The US FDA has granted Breakthrough Therapy Designation to Enhertu for use as post-neoadjuvant treatment in patients with HER2-positive early breast cancer, marking the tenth such designation for AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate, supported by phase III DESTINY-Breast05 trial results.

Quality / GMP | 23/12/2025 | By News Bureau |  196

US FDA Approves Roche's Lunsumio VELO for Subcutaneous Use in Follicular Lymphoma

The US FDA has approved Roche’s Lunsumio VELO for subcutaneous use in Relapsed or Refractory Follicular Lymphoma, cutting administration time to about one minute and supported by strong complete response data in later-line patients.

Quality / GMP | 22/12/2025 | By News Bureau |  318

Granules Pharma Gets US FDA Tentative Approval for Generic ADZENYS XR-ODT

Granules Pharmaceuticals Inc has received tentative approval from the US FDA for its generic version of Amphetamine Extended-Release Orally Disintegrating Tablets (ADZENYS XR-ODT), which will be manufactured at the company’s US-based facility in Chantilly, Virginia.

Quality / GMP | 22/12/2025 | By News Bureau |  236