News about "Food and Drug Administration "

Octant's OCT-980 Receives FDA Orphan Drug Designation for Retinitis Pigmentosa

Octant is evaluating OCT-980 in a Phase 1b/2 study at US sites, with the aim of developing a potential oral, disease-modifying treatment for RHO-adRP.

Food And Drug Administration | 29/10/2026 | By News Bureau

Alembic Pharma Gets US FDA Final Approval for Otic Suspension

Alembic Pharmaceuticals receives US FDA final approval for generic ciprofloxacin and dexamethasone otic suspension, targeting specified ear infections. The product’s US market is valued at USD 110 million.

Food And Drug Administration | 19/10/2026 | By News Bureau

Vir Biotechnology's VIR-5500 Receives FDA Fast Track Designation for Prostate Cancer

Vir Biotechnology and Astellas are advancing VIR-5500 for late-line metastatic castration-resistant prostate cancer following encouraging preliminary Phase 1 findings.

Food And Drug Administration | 12/10/2026 | By News Bureau |  106

Newron Reviews FDA Feedback on Evenamide Clinical Hold in US

Newron Pharmaceuticals is reviewing FDA feedback on the clinical hold in US study centres for its Phase 3 ENIGMA-TRS 2 trial of evenamide following potential cardiac safety concerns.

Food And Drug Administration | 12/10/2026 | By News Bureau |  107

Abbott Receives FDA Approval for CardioMEMS Patient App Updates

Abbott receives FDA approval for CardioMEMS HF System updates that enable eligible patients to view pulmonary artery pressure readings through the CardioGuide HF App.

Food And Drug Administration | 07/10/2026 | By News Bureau |  108

HUTCHMED, AstraZeneca Submit US NDA for Orpathys-Tagrisso Combination

AstraZeneca submits a US FDA NDA for Orpathys plus Tagrisso in MET-driven NSCLC following EGFR-TKI progression, supported by positive Phase 3 SAFFRON PFS and OS results.

Food And Drug Administration | 01/10/2026 | By News Bureau |  128

US FDA Inspection of Unichem's Goa Facility Ends With 5 Observations

US FDA conducted a six-day inspection at Unichem Laboratories’ Goa formulation facility, concluding with five observations related to procedural enhancements.

Food And Drug Administration | 30/09/2026 | By News Bureau |  108

Amneal Launches FDA-Approved Lanreotide Injection in the US

Amneal Pharmaceuticals has launched lanreotide injection in the US following FDA approval, expanding its complex injectable medicines portfolio.

Food And Drug Administration | 28/09/2026 | By News Bureau

AstraZeneca's Imfinzi Combo Gets US Priority Review for MIBC

AstraZeneca’s Imfinzi and enfortumab vedotin combination has received US FDA Priority Review based on positive Phase 3 VOLGA results in muscle-invasive bladder cancer.

Food And Drug Administration | 28/09/2026 | By News Bureau

Gossamer Bio Submits First NDA for Seralutinib in PAH

Gossamer Bio has filed an NDA for seralutinib, supported by Phase 3 PROSERA and Phase 2 TORREY study data.

Food And Drug Administration | 25/09/2026 | By News Bureau |  104