News about Quality / GMP

Harbour BioMed Secures China IND Approval for HBM7004 in Advanced Solid Tumours

NMPA clearance advances the B7H4xCD3 bispecific antibody toward clinical development, following promising preclinical efficacy and safety results and recent US FDA clearance.

Quality / GMP | 19/08/2026 | By News Bureau

Acurx Pharmaceuticals Secures FDA Conditional Acceptance of Cifbezy Name for Ibezapolstat

Acurx Pharmaceuticals has secured FDA conditional acceptance of Cifbezy as the proposed brand name for ibezapolstat and received USPTO trademark allowance, marking key preparatory milestones ahead of planned international Phase 3 development for C. difficile infection.

Quality / GMP | 18/08/2026 | By News Bureau

FDA Grants Emergency Use Authorization to Simparica TRIO for New World Screwworm in Dogs

The US FDA has granted Emergency Use Authorization for Zoetis’ Simparica TRIO to treat New World screwworm infestations in dogs and puppies. The authorization provides veterinarians with an additional treatment option as US authorities continue monitoring NWS detections in parts of Texas and New Mexico.

Quality / GMP | 17/08/2026 | By News Bureau

ArkBio's AK0406 Influenza Prophylaxis Drug Receives China IND Approval

ArkBio has secured China IND approval for AK0406, a long-acting antiviral Fc conjugate for influenza prophylaxis, marking the first influenza AFC candidate to enter clinical development in China.

Quality / GMP | 14/08/2026 | By News Bureau |  110

BioInvent's BI-1808 Receives FDA Fast Track Designation for Ovarian Cancer

BioInvent’s BI-1808 has received FDA Fast Track Designation for ovarian cancer, supporting accelerated development of the investigational anti-TNFR2 therapy in combination with pembrolizumab.

Quality / GMP | 11/08/2026 | By News Bureau

European Commission Approves Bavarian Nordic's MVA-BN Vaccine for Children Aged 2 and Older

Bavarian Nordic’s MVA-BN vaccine, Imvanex, is now authorised in the EU for children aged 2 years and older, expanding protection against mpox and smallpox among vulnerable populations.

Quality / GMP | 10/08/2026 | By News Bureau

RiboX Wins FDA IND Clearance for First Circular RNA-Based In Vivo CAR-T Therapy

RiboX Therapeutics receives FDA IND clearance for RXIM002, an investigational circRNA-based in vivo CAR-T therapy designed to generate CD19-targeted CAR-T cells directly inside the body for autoimmune cytopenias.

Quality / GMP | 10/08/2026 | By News Bureau |  197

Novartis' Rhapsido Gains UK Approval as First Oral BTK Inhibitor for Chronic Spontaneous Urticaria

Novartis has secured MHRA marketing authorisation for Rhapsido, the first oral Bruton’s tyrosine kinase inhibitor approved in the UK for adults with chronic spontaneous urticaria inadequately controlled by H1 antihistamines.

Quality / GMP | 10/08/2026 | By News Bureau |  131

Reckitt Secures FDA Approval for First OTC Cold and Flu Innovation in 14 Years

Reckitt has received U.S. FDA approval for Mucinex 12HR Cold and Fever Multi-Symptom, marking the first over-the-counter cold and flu innovation approved in 14 years. The product combines three active ingredients in a first-of-its-kind bilayer tablet designed to deliver extended relief for multiple cold and flu symptoms.

Quality / GMP | 06/08/2026 | By News Bureau |  161

Galibra Neuroscience Earns Dual FDA Designations for Gene Therapy Targeting Rare Neurological Disorder

Galibra Neuroscience has secured both Orphan Drug Designation and Rare Pediatric Disease Designation from the U.S. FDA for its investigational gene therapy for SSADH deficiency, strengthening regulatory support for a potential disease-modifying treatment aimed at addressing the genetic cause of the rare neurological disorder.

Quality / GMP | 06/08/2026 | By News Bureau