News about Quality / GMP

European Commission Expands Sanofi's MenQuadfi Approval to Include Infants from Six Weeks of Age

The European Commission has approved an expanded indication for Sanofi's MenQuadfi vaccine, allowing immunisation of infants from six weeks of age against invasive meningococcal disease caused by serogroups A, C, W and Y.

Quality / GMP | 05/08/2026 | By News Bureau |  102

US FDA Grants Breakthrough Therapy Designation to Lilly's Olomorasib for Advanced Pancreatic Cancer

The US FDA has granted Breakthrough Therapy designation to Eli Lilly's investigational KRAS G12C inhibitor, olomorasib, for treating previously treated advanced pancreatic cancer, reinforcing its potential across difficult-to-treat KRAS-driven cancers.

Quality / GMP | 04/08/2026 | By News Bureau |  104

Innogen Wins PIC/S GMP Certification for Efsubaglutide Alfa

Innogen Pharmaceuticals has secured PIC/S GMP certification, validating its manufacturing quality and supporting the global expansion of efsubaglutide alfa.

Quality / GMP | 04/08/2026 | By News Bureau |  148

Cipla's InvaGen Receives US FDA EIR for New York Manufacturing Facility

Cipla's subsidiary InvaGen has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA), marking the successful closure of the inspection at its New York facility.

Quality / GMP | 04/08/2026 | By News Bureau |  137

US FDA Approves Lupin's Generic Diazepam Injection in Prefilled Syringe Format

Lupin has secured US FDA approval for its generic diazepam injection USP in a single-dose prefilled syringe format. The bioequivalent version of Roche's Valium injection expands the company's US injectable portfolio and addresses a market valued at nearly USD 78 million annually.

Quality / GMP | 04/08/2026 | By News Bureau |  101

US FDA Approves Dr Reddy's Rituximab Biosimilar for the US Market

Dr Reddy's Laboratories has secured US FDA approval for its rituximab biosimilar, expanding its global biosimilars portfolio and strengthening its presence in the US biologics market.

Quality / GMP | 03/08/2026 | By News Bureau

Iksuda Therapeutics Secures US FDA IND Clearance for Novel ADC Candidate IKS04 in GI Cancers

Phase 1 trial to evaluate first-of-its-kind CA242-targeted antibody-drug conjugate with an innovative co-administration regimen designed to improve solid tumour penetration and therapeutic efficacy.

Quality / GMP | 03/08/2026 | By News Bureau

Aspen Neuroscience's Parkinson's Cell Therapy Receives US FDA RMAT Designation

Aspen Neuroscience has received US FDA Regenerative Medicine Advanced Therapy designation for sasineprocel (ANPD001), its investigational autologous cell therapy for Parkinson's disease.

Quality / GMP | 31/07/2026 | By News Bureau |  141

US FDA Approves Teleflex's Ezplaz Freeze Dried Plasma, First Licensed FDP in the US

Teleflex has received US FDA Biologics License Application (BLA) approval for Ezplaz Freeze Dried Plasma, the first FDA-licensed freeze-dried plasma product in the United States.

Quality / GMP | 31/07/2026 | By News Bureau |  102

Qnovia Secures Global License for Novel Antimicrobial Peptide to Combat Drug-Resistant Infections

Qnovia has obtained worldwide exclusive rights from the University of Virginia to develop and commercialise the D8 antimicrobial peptide, a novel therapy designed to target multidrug-resistant bacterial infections through a unique mechanism.

Quality / GMP | 31/07/2026 | By News Bureau