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News about Quality / GMP
Armata Pharmaceuticals Receives FDA Fast Track Designation for AP-SA02 Bacteriophage Therapy
The FDA has granted Fast Track designation to Armata’s AP-SA02 therapy for the adjunct treatment of complicated Staphylococcus aureus bacteremia caused by MSSA and MRSA infections.
Quality / GMP | 07/05/2026 | By News Bureau | 198
Atossa Therapeutics receives US Food and Drug Administration (FDA) Rare Pediatric Disease designation for (Z)-Endoxifen in McCune-Albright syndrome, qualifying for Priority Review Voucher award upon approval.
Quality / GMP | 05/05/2026 | By News Bureau | 149
Australia Approves First-in-Class Niktimvo for Chronic GVHD Treatment
Niktimvo approval marks a major breakthrough in treating chronic GVHD, introducing a first-in-class targeted therapy for patients with limited treatment options and high unmet medical need.
Quality / GMP | 05/05/2026 | By News Bureau | 114
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 | 217
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 | 222
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 | 168
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 | 135
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 | 187
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 | 197
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 | 257
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