News about Quality / GMP

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 |  165

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 |  160

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 |  133

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 |  162

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 |  267

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 |  124

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 |  149

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 |  348

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 |  139