Last edition
News about Quality / GMP
FDA Grants Priority Review to Sanofi's Venglustat for Type 3 Gaucher Disease
Sanofi’s brain-penetrant investigational therapy venglustat has received FDA priority review after phase 3 data demonstrated positive efficacy and safety outcomes in patients with type 3 Gaucher disease.
Quality / GMP | 29/05/2026 | By News Bureau | 146
GSK Reports Positive Phase 3 Results for Bepirovirsen in Chronic Hepatitis B Treatment
GSK’s investigational antisense oligonucleotide bepirovirsen demonstrated statistically significant functional cure rates in chronic hepatitis B patients, offering a potential alternative to lifelong antiviral therapy.
Quality / GMP | 29/05/2026 | By News Bureau | 353
Indoco Remedies Secures EU GMP Certification for Baddi Formulation Plant III
Indoco Remedies has received EU GMP certification for its Baddi Plant III formulation facility following a successful inspection conducted in April 2026.
Quality / GMP | 28/05/2026 | By News Bureau | 274
Pharming Secures EU Approval for Joenja as First Targeted Treatment for Rare Immune Disorder APDS
Pharming Group has received European Commission approval for Joenja, expanding treatment access for patients with activated PI3K delta syndrome and strengthening therapeutic options for rare immune disorders.
Quality / GMP | 26/05/2026 | By News Bureau | 126
Junshi Biosciences expands toripalimab’s treatment footprint in China with regulatory approval for a new urothelial carcinoma indication, strengthening immunotherapy options for patients with advanced bladder cancer.
Quality / GMP | 25/05/2026 | By News Bureau | 145
Qihan Biotech Secures US FDA IND Clearance for Next-Generation Universal CAR-T Therapy QT-019C
Qihan Biotech has received US FDA Investigational New Drug clearance for QT-019C, an off-the-shelf universal CAR-T therapy designed to improve safety, accessibility and treatment outcomes for patients with autoimmune diseases.
Quality / GMP | 22/05/2026 | By News Bureau | 352
Bayer Receives FDA Priority Review for Kerendia in Type 1 Diabetes-Related Kidney Disease
Bayer receives US Food and Drug Administration (FDA) Priority Review (PR) for supplemental approval of Kerendia to treat adults with Type 1 Diabetes (T1D) and Chronic Kidney Disease (CKD), potentially becoming the first Mineralocorticoid Receptor Antagonist (MRA) approved for this patient population.
Quality / GMP | 22/05/2026 | By News Bureau | 166
Sunrise Air Receives US FDA Clearance, Expanding Access to At-Home Sleep Apnoea Diagnosis
Sunrise Air, Sunrise Group’s FDA-cleared next-generation home sleep testing device, combines AI-powered analysis and advanced sensor technology to deliver accessible, clinically robust sleep apnoea diagnosis from home.
Quality / GMP | 21/05/2026 | By News Bureau | 221
Accord BioPharma has received US FDA approval for Immgolis and Immgolis Intri, the first golimumab biosimilars approved in the United States for rheumatoid arthritis and ulcerative colitis treatment.
Quality / GMP | 19/05/2026 | By News Bureau | 230
Racura Oncology Advances RC220 to Higher Dose Level in Phase 1 CPACS Cancer Trial
Racura Oncology has received approval from the Safety Review Committee to escalate the dose of investigational cancer therapy RC220 in its phase 1 CPACS clinical trial following positive safety findings in advanced metastatic cancer patients.
Quality / GMP | 19/05/2026 | By News Bureau | 141
We use our own and third party cookies to produce statistical information and show you personalized advertising by analyzing your browsing, according to our COOKIES POLICY. If you continue visiting our Site, you accept its use.
More information: Privacy Policy