News about "US FDA "

Moberg Pharma Secures US Patent for Improved MOB-015 Dosing Regimen

Moberg Pharma secures US patent for an improved dosing regimen of MOB-015, strengthening its intellectual property portfolio through December 2041.

US FDA | 04/11/2026 | By News Bureau

AbbVie Files US FDA BLA for Etentamig in Multiple Myeloma

AbbVie has submitted Biologics License Application (BLA) for Etentamig to US FDA for adults living with Relapsed/Refractory Multiple Myeloma (RRMM).

US FDA | 03/11/2026 | By News Bureau |  126

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.

US FDA | 29/10/2026 | 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.

US FDA | 12/10/2026 | By News Bureau |  129

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.

US FDA | 12/10/2026 | By News Bureau |  119

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.

US FDA | 07/10/2026 | By News Bureau |  146

Litfulo Shows Significant Repigmentation Benefits in Phase 3

Pfizer’s two phase 3 trials showed significant improvements in facial and total body repigmentation compared with placebo.

US FDA | 05/10/2026 | By News Bureau

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.

US FDA | 28/09/2026 | By News Bureau

FDA Panel Backs GRAIL's Galleri Multi-Cancer Detection Test

The US Food and Drug Administration advisory panel backed Galleri’s safety and voted that its benefits outweigh risks, while six of 10 members supported its effectiveness.

US FDA | 25/09/2026 | By News Bureau

Envoy Medical Expands Global IP Portfolio to 97 Patents

Envoy Medical secures two additional international patents, taking its global granted patent portfolio to 97 across the US and foreign markets.

US FDA | 24/09/2026 | By News Bureau |  117