News about "Food and Drug Administration "

Aurobindo Pharma Unit Receives US FDA Warning Letter; No Impact on US Supplies

Aurobindo Pharma’s Eugia Pharma Specialities has received a US FDA warning letter for its Telangana facility, while the company said existing US supplies remain unaffected.

Food And Drug Administration | 14/08/2026 | By News Bureau

Maharashtra FDA Warns Drug Applicants Against Unauthorised Agents, Intermediaries

Maharashtra FDA has warned drug manufacturers, wholesalers and retailers against unauthorised agents demanding money for licences and urged applicants to use the official online system directly.

Food And Drug Administration | 14/08/2026 | By News Bureau

US FDA Grants Accelerated Approval to BMS' ZENBEXUS for Multiple Myeloma

The US Food and Drug Administration (FDA) has granted accelerated approval to Bristol Myers Squibb’s (BMS) ZENBEXUS, a first-in-class CELMoD therapy combined with daratumumab and dexamethasone for multiple myeloma.

Food And Drug Administration | 14/08/2026 | By News Bureau

FDA Clears Graviton BioScience's GV101 for Phase 2 Development in Friedreich's Ataxia

Graviton BioScience has received FDA IND clearance for a new GV101 capsule formulation, paving the way for a Phase 2 trial in patients with Friedreich’s ataxia.

Food And Drug Administration | 12/08/2026 | By News Bureau |  170

Zydus Lifesciences Reports 22 Percent Revenue Growth in Q1 FY27, Advances Innovation Pipeline

Zydus Lifesciences began FY27 with strong double-digit growth, driven by robust performance across India and international formulations, alongside continued progress in manufacturing quality and biosimilar innovation.

Food And Drug Administration | 12/08/2026 | By News Bureau

BioInvent's BI-1808 Receives FDA Fast Track Designation for Ovarian Cancer

BioInvent’s BI-1808 has received FDA Fast Track Designation for ovarian cancer, supporting accelerated development of the investigational anti-TNFR2 therapy in combination with pembrolizumab.

Food And Drug Administration | 11/08/2026 | By News Bureau

RiboX Wins FDA IND Clearance for First Circular RNA-Based In Vivo CAR-T Therapy

RiboX Therapeutics receives FDA IND clearance for RXIM002, an investigational circRNA-based in vivo CAR-T therapy designed to generate CD19-targeted CAR-T cells directly inside the body for autoimmune cytopenias.

Food And Drug Administration | 10/08/2026 | By News Bureau

Nipro Launches FDA-Cleared ELISIO-HX Dialyzer to Expand Hemodialysis Access in the U.S.

Nipro Medical Corporation has commercially launched the FDA-cleared ELISIO-HX dialyzer in the U.S., introducing an expanded hemodialysis solution that enhances middle molecule removal while integrating seamlessly into existing dialysis workflows without requiring new equipment.

Food And Drug Administration | 06/08/2026 | By News Bureau

Reckitt Secures FDA Approval for First OTC Cold and Flu Innovation in 14 Years

Reckitt has received U.S. FDA approval for Mucinex 12HR Cold and Fever Multi-Symptom, marking the first over-the-counter cold and flu innovation approved in 14 years. The product combines three active ingredients in a first-of-its-kind bilayer tablet designed to deliver extended relief for multiple cold and flu symptoms.

Food And Drug Administration | 06/08/2026 | By News Bureau

Galibra Neuroscience Earns Dual FDA Designations for Gene Therapy Targeting Rare Neurological Disorder

Galibra Neuroscience has secured both Orphan Drug Designation and Rare Pediatric Disease Designation from the U.S. FDA for its investigational gene therapy for SSADH deficiency, strengthening regulatory support for a potential disease-modifying treatment aimed at addressing the genetic cause of the rare neurological disorder.

Food And Drug Administration | 06/08/2026 | By News Bureau