News about Quality / GMP

US FDA Clears Sotyktu for Active Psoriatic Arthritis

The US Food and Drug Administration (FDA) has approved Sotyktu, developed by Bristol Myers Squibb, for adults with active psoriatic arthritis. The once-daily oral TYK2 inhibitor showed significantly higher ACR20 response rates versus placebo in the phase-III POETYK PsA-1 and PsA-2 trials.

Quality / GMP | 07/03/2026 | By News Bureau |  147

Glenmark Specialty SA Receives US FDA Approval for Fluticasone Propionate Inhalation Aerosol USP

Glenmark Pharmaceuticals’s subsidiary Glenmark Specialty SA has received approval from the US Food and Drug Administration (FDA) for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation, along with 180-day Competitive Generic Therapy exclusivity. The product has been deemed bioequivalent and therapeutically equivalent to Flovent HFA.

Quality / GMP | 05/03/2026 | By Akanki |  162

Japan Grants Orphan Drug Designation to Sanofi's Rilzabrutinib

Sanofi’s rilzabrutinib has received Orphan Drug Designation in Japan for IgG4-related disease (IgG4-RD), supported by positive phase-II study results. The decision marks the therapy’s third global orphan designation in this indication, underscoring Sanofi’s continued focus on advancing treatments for rare immune-mediated diseases.

Quality / GMP | 02/03/2026 | By News Bureau |  176

FDA Clears Novo Nordisk's Sogroya for Three New Paediatric Uses

The US Food and Drug Administration (FDA) has approved Novo Nordisk’s Sogroya for three additional paediatric indications, expanding its use in children aged 2.5 years and older and reinforcing its position as the only once-weekly, long-acting growth hormone with the broadest approved label.

Quality / GMP | 02/03/2026 | By News Bureau |  194

WuXi Vaccines Receives Brazil's ANVISA GMP Certification

Based on the commercial manufacturing agreement with Instituto Butantan and Fundação Butantan, WuXi Vaccines will provide end-to-end services including drug substance and drug product manufacturing and quality control.

Quality / GMP | 12/02/2026 | By News Bureau |  209

US FDA Clears Anuh Pharma Facility with No Form 483 Observations

The Tarapur facility of Anuh Pharma is already an EUGMP/ WHO pre-qualified approved manufacturing facility with nine API’s blocks and two intermediate block with total capacity of 2400 MTPA.

Quality / GMP | 11/02/2026 | By News Bureau |  224

China Grants Priority Review to Leqembi Subcutaneous BLA

The Priority Review and Approval Procedure has been implemented by the NMPA with the aim of accelerating research, development and launch of new medicines that have significant clinical value. Under this procedure, the assessment period is expected to be shortened.

Quality / GMP | 11/02/2026 | By News Bureau |  179

Akums Receives First UK MHRA Approval for Rivaroxaban

Rivaroxaban is an oral anticoagulant prescribed for the prevention and treatment of thromboembolic disorders, including Non-Valvular Atrial Fibrillation (NVAF), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE) and clinically relevant cardiovascular risk reduction.

Quality / GMP | 10/02/2026 | By News Bureau |  200

DIFF Biotech's Nasal Spray Influenza Vaccine Receives Clinical Trial Approval

As the first domestically self-developed nasal spray influenza vaccine in China to advance into clinical trial, DIFF-flu, manufactured by DIFF Biotech, leverages a pioneering M2 gene–modified attenuation technology, protected by multiple international invention patents.

Quality / GMP | 10/02/2026 | By News Bureau |  127

Akeso Secures Fifth NMPA Breakthrough Designation for Ivonescimab

The breakthrough designation supports ivonescimab combined with chemotherapy for first-line treatment of advanced Biliary Tract Cancer (BTC), based on an ongoing phase-III study comparing it with durvalumab-based chemotherapy.

Quality / GMP | 07/02/2026 | By News Bureau |  316