News about Quality / GMP

US FDA Approves Sanofi's Tzield to Delay Type 1 Diabetes Progression in Children

Sanofi’s Tzield gains US FDA approval to delay stage-III Type 1 Diabetes in children aged one year and above, the first disease-modifying therapy for stage-II T1D.

Quality / GMP | 24/04/2026 | By News Bureau

Australia Approves MINJUVI (tafasitamab) for Relapsed or Refractory Follicular Lymphoma

Australia approves MINJUVI (tafasitamab) with rituximab and lenalidomide, the first chemo-free dual-targeted therapy for relapsed follicular lymphoma.

Quality / GMP | 24/04/2026 | By News Bureau

WuXi Biologics Secures South Korea GMP Certification for Key Manufacturing Facilities

The South Korea GMP Certification from the Ministry of Food and Drug Safety strengthens WuXi Biologics’ end-to-end capabilities for commercial production of complex biologics, including cancer therapies.

Quality / GMP | 23/04/2026 | By News Bureau

Merck Wins FDA Approval for Once-Daily IDVYNSO (Doravirine/Islatravir)

IDVYNSO is approved for adults with virologically suppressed HIV-1 with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine.

Quality / GMP | 23/04/2026 | By News Bureau

OneSource and Orbicular Receive US FDA Tentative Approval for Generic Semaglutide

OneSource and Orbicular secure US FDA tentative approval for generic semaglutide injection, advancing ANDA filing for Ozempic with manufacturing support from OneSource.

Quality / GMP | 22/04/2026 | By News Bureau |  162

Roche Secures FDA Review for Lupus Drug Gazyva

Roche’s Gazyva moves closer to approval for systemic lupus erythematosus after FDA accepts application backed by Phase III trial results showing improved disease control and remission rates.

Quality / GMP | 22/04/2026 | By News Bureau

FDA Grants Priority Review to Astellas and Pfizer's Bladder Cancer Combination Therapy

Astellas and Pfizer’s Padcev-Keytruda combination moves closer to expanded approval, offering a potential new treatment option to reduce recurrence and improve survival in bladder cancer patients.

Quality / GMP | 21/04/2026 | By News Bureau

Morepen Laboratories Bags Zero-Observation USFDA Inspection for Fourth Time

Morepen Laboratories clears its fourth consecutive USFDA inspection at the Masulkhana facility with zero observations (NIL 483), reinforcing its CDMO strength following a INR 825 crore global manufacturing mandate.

Quality / GMP | 21/04/2026 | By News Bureau

GSK plc Secures China Approval for Blenrep Combination Therapy in Multiple Myelom

National Medical Products Administration approves Blenrep with bortezomib and dexamethasone for relapsed or refractory patients, backed by strong phase III trial outcomes.

Quality / GMP | 21/04/2026 | By News Bureau

Rusan Pharma Wins Japan PMDA GMP Nod for Two Key Plants

Rusan Pharma secures Japan PMDA GMP approval for its Ankleshwar and Dehradun facilities, covering both API and finished manufacturing dosage units.

Quality / GMP | 21/04/2026 | By News Bureau |  102