News about Quality / GMP

Akums Secures EU GMP Approval for Two Haridwar Facilities

The approvals follow successful EU-GMP audits of Akums’ two Haridwar manufacturing facilities, with the drug regulator renewing certification for plant I and granting fresh approval to plant II after assessing operations, quality systems, documentation and compliance with EU GMP standards.

Quality / GMP | 23/01/2026 | By News Bureau |  200

FDA Grants Orphan Drug Status to BlueRock's OpCT-001

The ODD supports the clinical development of OpCT-001, the first iPSC-derived investigational cell therapy to enter human trials for Retinitis Pigmentosa (RP), a common inherited retinal disease marked by progressive loss of photoreceptor cells.

Quality / GMP | 23/01/2026 | By News Bureau |  290

D3 Bio Secures FDA IND Clearance for Two Oncology Programmes

The US FDA has cleared two Investigational New Drug (IND) applications from D3 Bio, paving the way for a phase I clinical trial of D3S-003 and a phase II combination study evaluating elisrasib (D3S-001) with D3S-002, marking a key step forward in the company’s oncology development pipeline.

Quality / GMP | 23/01/2026 | By News Bureau |  320

EMA Recommends Record 30 Veterinary Medicines for Approval in 2025

The European Medicines Agency (EMA) has released an overview of its key recommendations for 2025 concerning the authorisation and safety monitoring of veterinary medicines.

Quality / GMP | 21/01/2026 | By Darshana |  432

ImmunityBio Advances FDA Talks on ANKTIVA Resubmission

ImmunityBio said the FDA has requested additional information to potentially support a resubmission of the sBLA for ANKTIVA in BCG-unresponsive papillary bladder cancer, without requiring new clinical trials, with the company planning to submit the data within 30 days.

Quality / GMP | 21/01/2026 | By News Bureau |  263

FDA Grants Orphan Drug Designation to LP-284 of Lantern Pharma

The designation marks the third FDA orphan status for LP-284 and the sixth across Lantern Pharma’s AI-driven oncology pipeline, strengthening the programme’s development momentum in soft tissue sarcomas, a rare cancer segment with significant unmet need and a growing global market.

Quality / GMP | 21/01/2026 | By News Bureau |  152

EU Validates ENHERTU Plus Pertuzumab for First-Line HER2-Positive Metastatic Breast Cancer

The European Union (EU) has validated the first-line use of ENHERTU in combination with pertuzumab for patients with HER2-positive metastatic breast cancer, following results from the DESTINY-Breast09 phase-III trial, which demonstrated a significant improvement in Progression-Free Survival (PFS) compared to current standard treatments.

Quality / GMP | 20/01/2026 | By News Bureau |  197

Elanco Expands TruCan Vaccine Portfolio with USDA-Approved Oral Bordetella Shot

Elanco Animal Health Incorporated has received approval from the US Department of Agriculture (USDA) for TruCan Ultra B (Oral), a next-generation oral vaccine designed to protect dogs against Bordetella bronchiseptica, a key cause of canine infectious respiratory disease complex (CIRDC), commonly known as kennel cough.

Quality / GMP | 19/01/2026 | By Darshana |  191

FDA Acknowledges Pain Reduction Data Supporting Rexlemestrocel-L Efficacy

The US Food and Drug Administration (FDA) has acknowledged clinical data showing that Rexlemestrocel-L reduced pain intensity over 12 months, supporting the product’s efficacy in treating back pain. The agency also indicated that the approval label may include language related to opioid reduction.

Quality / GMP | 19/01/2026 | By News Bureau |  138

UK MHRA Approves up to 7.2 mg Dose of Semaglutide for Obesity Treatment

The UK MHRA has approved a higher dose of semaglutide of up to 7.2 mg for weight management in adult patients with obesity. The regimen involves three 2.4 mg injections and is indicated for use alongside a reduced-calorie diet and increased physical activity in adults with a Body Mass Index (BMI) of 30 kg/m² or higher.

Quality / GMP | 17/01/2026 | By News Bureau |  141