News about Quality / GMP

Immix Biopharma Gets US FDA Breakthrough Therapy Designation for NXC-201

Immix Biopharma has received US FDA Breakthrough Therapy Designation for its CAR-T candidate NXC-201, based on positive interim phase-II results from the NEXICART-2 study presented at the ASH 2025 annual meeting, with final data expected later this year followed by a planned Biologics Licence Application (BLA) submission.

Quality / GMP | 29/01/2026 | By News Bureau |  198

Sun Pharma Wins DCGI Nod for Generic Semaglutide Injection

Sun Pharmaceutical has secured approval from the Drugs Controller General of India (DCGI) to manufacture and market a generic semaglutide injection for chronic weight management, paving the way for its entry into the fast-growing obesity treatment segment once the semaglutide patent expires in the country.

Quality / GMP | 27/01/2026 | By News Bureau |  329

China Approves Trelegy Ellipta for Uncontrolled Asthma

China has approved Trelegy Ellipta for adults with uncontrolled asthma, extending its use beyond COPD and making it the only single-inhaler triple therapy for both conditions in the country.

Quality / GMP | 27/01/2026 | By News Bureau |  325

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 |  317

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 |  415

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 |  499

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 |  574

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 |  317

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 |  226

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 |  265