News about Quality / GMP

Lupin Receives US FDA Approval for Glycerol Phenylbutyrate Oral Liquid

Lupin secures US Food and Drug Administration (FDA) approval for Glycerol Phenylbutyrate Oral Liquid (1.1 g/mL), bioequivalent to Ravicti Oral Liquid.

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

OneSource-Backed Generic Semaglutide Secures Health Canada Approval

Orbicular and OneSource Specialty Pharma achieve a major milestone with Canada’s second generic Ozempic approval, strengthening their position in global peptide-based injectable markets.

Quality / GMP | 04/05/2026 | By News Bureau

Axsome Therapeutics Secures US Food and Drug Administration Approval for Auvelity in Alzheimer's Agitation

First-in-class therapy approved to treat agitation linked to Alzheimer’s disease, addressing a major unmet need for patients and caregivers.

Quality / GMP | 04/05/2026 | By News Bureau

Emergent BioSolutions Secures Singapore Approval to Expand ACAM2000 Use for Mpox Prevention

Health Sciences Authority clears expanded indication of ACAM2000 for high-risk adults, strengthening preparedness against mpox outbreaks.

Quality / GMP | 04/05/2026 | By News Bureau

UK MHRA Approves Linerixibat (Lynavoy) for Biliary Disease Itch

The UK Medicines and Healthcare products Regulatory Agency (MHRA) approves linerixibat (lynavoy) for treating itch associated with biliary tract disease, with ongoing monitoring of safety and effectiveness.

Quality / GMP | 04/05/2026 | By News Bureau

Lakewood-Amedex Biotherapeutics Reports Promising AMR Data for Nu-3 in Diabetic Foot Ulcer Treatment

Lakewood-Amedex advances Nu-3 as a potential breakthrough topical therapy to combat antibiotic-resistant infections in diabetic foot ulcers.

Quality / GMP | 01/05/2026 | By News Bureau

GSK's Efimosfermin Secures FDA Breakthrough and EMA PRIME Status for MASH Treatment

The dual regulatory designations from US FDA and European Medicines Agency fast-track development of GSK’s investigational liver therapy for metabolic dysfunction-associated steatohepatitis.

Quality / GMP | 29/04/2026 | By News Bureau |  108

Jazz Pharmaceuticals Secures FDA Priority Review for Ziihera in First-Line HER2 plus Gastroesophageal Cancer

U.S. Food and Drug Administration accepts sBLA for Ziihera with Priority Review, backed by Phase III data showing improved outcomes in HER2-positive advanced gastric and gastroesophageal cancers.

Quality / GMP | 29/04/2026 | By News Bureau

Novartis Secures EC Approval for First Oral Targeted CSU Drug Rhapsido

Novartis introduces Rhapsido in Europe, offering a first-of-its-kind oral targeted therapy for patients with chronic spontaneous urticaria.

Quality / GMP | 28/04/2026 | By News Bureau

Alembic Pharmaceuticals Secures US FDA Nod for Fingolimod Capsules

Alembic Pharmaceuticals receives US FDA approval for fingolimod capsules, expanding access to a key multiple sclerosis treatment in the US market.

Quality / GMP | 27/04/2026 | By News Bureau