News about "US FDA "

NanoMosaic Secures FDA AMT Designation for Nanoneedle Technology in AAV Gene Therapy Manufacturing

FDA’s CBER grants Advanced Manufacturing Technology designation to NanoMosaic’s Nanoneedle platform, enhancing regulatory engagement and streamlining quality control in AAV gene therapy production.

US FDA | 30/01/2026 | By News Bureau

Avobis Bio to Present Expanded STOMP2 Trial Data on AVB-114 at ECCO Congress

Expanded STOMP2 trial data highlight sustained safety and efficacy of AVB-114, as Avobis Bio prepares for Phase III development in Crohn’s disease.

US FDA | 30/01/2026 | By News Bureau

US FDA Delays Two Drug Reviews Under New Priority Voucher Program

The U.S. Food and Drug Administration (FDA) has delayed the review of two medicines selected under its recently launched Commissioner’s National Priority Voucher Program, after regulators raised concerns related to safety and clinical effectiveness.

US FDA | 16/01/2026 | By Darshana |  254

US FDA Places Sun Pharma's Baska Facility Under 'Official Action Indicated' After Inspection

Sun Pharmaceutical Industries Ltd said the U.S. Food and Drug Administration (FDA) has assigned an “Official Action Indicated” (OAI) status to its Baska manufacturing facility following a recent regulatory inspection.

US FDA | 18/12/2025 | By Darshana |  149

US FDA Approves Phase III Trial of Cadonilimab Against Nivolumab in Gastric Cancer

The FDA’s clearance enables a global phase III study evaluating Cadonilimab, in combination with chemotherapy, as a first-line option for HER2-negative, unresectable or metastatic gastric and gastroesophageal junction adenocarcinoma, directly comparing its efficacy to standard chemotherapy with or without Nivolumab.

US FDA | 12/12/2025 | By Akanki |  180

Zaynich milestone: First Indian-developed NCE accepted by US FDA

Wockhardt Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for its novel, first-in-class antibiotic Zaynich.

US FDA | 02/12/2025 | By Darshana |  211

Lupin Secures US FDA Approval for Pegfilgrastim Biosimilar Armlupeg

Lupin has received approval from the U.S. Food and Drug Administration (FDA) for its biosimilar Armlupeg (pegfilgrastim-unne), marking an important milestone in the company’s biologics journey. Armlupeg is a biosimilar to Neulasta (pegfilgrastim), a widely used therapy that helps reduce infection risk in cancer patients undergoing chemotherapy.

US FDA | 01/12/2025 | By Darshana |  161

US FDA Grants Six More Priority Review Vouchers to Accelerate Drug Approvals

The US Food and Drug Administration (FDA) has awarded six additional companies under its “Commissioner’s National Priority Voucher” programme, bringing the total number of recipients to fifteen.

US FDA | 07/11/2025 | By Darshana |  152

WINREVAIR from Merck Gains Updated FDA Indication for Pulmonary Arterial Hypertension

Adding WINREVAIR from Merck to background PAH therapy improved exercise capacity and WHO Functional Class (FC), and reduced the risk of clinical worsening events, including hospitalisation for PAH, lung transplantation and death.

US FDA | 29/10/2025 | By Dineshwori |  175

FDA Approves Oral Semaglutide by Novo Nordisk for CV Risk Reduction in Adults with Type 2 Diabetes

Rybelsus (Semaglutide) tablets, available in 7 mg and 14 mg doses, is the only FDA-approved oral GLP-1 therapy, and is now indicated to lower the risk of Major Adverse Cardiovascular Events (MACE)—including CV death, heart attack, or stroke—in adults with type 2 diabetes at high cardiovascular risk.

US FDA | 21/10/2025 | By Dineshwori |  201