News about Quality / GMP

Celltrion Gets FDA Nod for 300mg OMLYCLO, the First Interchangeable Xolair Biosimilar

The US FDA has approved 300 mg/2 mL prefilled syringe formulation of OMLYCLO (omalizumab-igec), expanding dosing options for patients with certain allergic diseases and supporting more personalised treatment. OMLYCLO—the first and only biosimilar interchangeable with XOLAIR (omalizumab)—previously received approval for its 75 mg and 150 mg strengths.

Quality / GMP | 03/12/2025 | By Dineshwori |  182

Glenmark's Aurangabad Facility Clears US FDA Inspection With Zero Observations

Glenmark Pharmaceuticals announced that the US Food and Drug Administration (US FDA) has successfully completed a pre-approval inspection of its formulations manufacturing facility in Chhatrapati Sambhajinagar (Aurangabad).

Quality / GMP | 01/12/2025 | By Dineshwori |  471

Novo Nordisk Files for FDA Approval of Wegovy Injection 7.2 mg

Novo Nordisk has filed an sNDA with the US FDA for a 7.2 mg dose of Wegovy, aiming to offer a higher-dose option for adults with obesity. The application, supported by STEP UP trial data showing 20.7 percent average weight loss, will be reviewed under the FDA’s expedited CNPV pathway.

Quality / GMP | 29/11/2025 | By Dineshwori |  356

US FDA Classifies Biocon Biologics' Bengaluru Drug Substance Facility as VAI

The US FDA has classified Biocon Biologics’ Bengaluru drug substance facility as Voluntary Action Indicated (VAI) following an inspection in August–September 2025. The review covers the site’s production of rh-Insulin and biosimilar Pegfilgrastim for the US market.

Quality / GMP | 29/11/2025 | By Dineshwori |  235

FDA Grants Priority Review to Sonrotoclax to Treat Relapsed/Refractory Mantle Cell Lymphoma

The priority review positions sonrotoclax to potentially become the first BCL2 inhibitor approved in the U.S. for relapsed or refractory mantle cell lymphoma, offering a promising new option for patients with this aggressive and hard-to-treat cancer.

Quality / GMP | 28/11/2025 | By Dineshwori |  180

Glenmark Pharmaceuticals Receives EIR from US FDA for Monroe Facility

Glenmark Pharmaceuticals has received an Establishment Inspection Report (EIR) from the US FDA for its formulations manufacturing facility in Monroe, with a Voluntary Action Indicated (VAI) status.

Quality / GMP | 27/11/2025 | By Dineshwori |  241

US FDA Approves Label Update for Sun Pharma's UNLOXCYT

Sun Pharma has received US FDA approval for a label update to UNLOXCYT, the first and only PD-L1 inhibitor for advanced Cutaneous Squamous Cell Carcinoma (aCSCC), further supporting its clinical value with durable responses and a favourable safety profile for patients with multiple comorbidities.

Quality / GMP | 27/11/2025 | By Dineshwori |  192

Piramal Pharma Solutions' Grangemouth Facility Receives Updated MHRA GMP Certificates

Piramal Pharma Solutions's Grangemouth facility in the UK has received updated MHRA GMP certificates following a successful compliance report and desktop inspection.

Quality / GMP | 19/11/2025 | By Dineshwori |  239

Alembic Pharmaceuticals Receives USFDA Final Approval for Diltiazem Hydrochloride Tablets

Alembic Pharmaceuticals has received final approval from the USFDA for its Diltiazem Hydrochloride Tablets in multiple strengths, a generic version of Cardizem used for managing certain types of angina. The approval adds to the company’s growing US portfolio, bringing its total ANDA count to 230, including 210 final and 20 tentative approvals.

Quality / GMP | 18/11/2025 | By Dineshwori |  149

EMA Recommends EU Approval for Waskyra to Treat Wiskott-Aldrich Syndrome

The EMA has recommended EU marketing authorisation for Waskyra (etuvetidigene autotemcel), a gene therapy for patients aged six months and older with Wiskott-Aldrich Syndrome (WAS). The treatment uses a patient’s own modified stem cells to restore functional WAS protein.

Quality / GMP | 17/11/2025 | By Dineshwori |  246