News about Quality / GMP

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 |  165

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 |  427

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 |  208

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 |  282

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 |  143

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 |  195

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 |  163

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 |  112

Novo Nordisk Seeks FDA Approval for CagriSema Weight-Loss Therapy

CagriSema 2.4 mg/2.4 mg is an investigational once-weekly injectable combining cagrilintide and semaglutide to target complementary obesity pathways. In the REDEFINE 1 phase III trial, patients with obesity or overweight achieved an average weight loss of 23 percent, reinforcing the company’s ongoing focus on innovation in obesity treatment.

Quality / GMP | 19/12/2025 | By News Bureau |  220

Kiora Secures New Patent for Novel KIO-104 Formulation

Kiora Pharmaceuticals, Inc., a clinical-stage biotechnology company, announced that the US Patent and Trademark Office has issued a new patent (US-12,472,263) covering additional novel formulations within the KIO-100 family of compounds.

Quality / GMP | 03/12/2025 | By Darshana |  125