News about Quality / GMP

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

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

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 |  107

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

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 |  132

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

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

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

Sanofi's Efdoralprin Alfa Gains EU Orphan Designation for AATD Emphysema

Sanofi’s investigational restorative recombinant therapy efdoralprin alfa has received EU orphan drug designation for alpha-1 antitrypsin deficiency–related emphysema, following positive phase II head-to-head results demonstrating success across all primary and key secondary endpoints versus the current plasma-derived standard of care.

Quality / GMP | 20/12/2025 | By News Bureau