News about "USFDA approval"

Organon Wins FDA Approval to Extend Duration of Use for NEXPLANON

Organon has received US Food and Drug Administration (FDA) approval for a supplemental New Drug Application extending the duration of use of NEXPLANON, its etonogestrel radiopaque contraceptive implant, to up to five years, expanding the product’s earlier three-year indication and offering longer-lasting contraceptive protection.

USFDA Approval | 17/01/2026 | By News Bureau |  237

Bionpharma Wins FDA Approval for Etravirine Tablets in Partnership with STEERLife

The US FDA approval clears the way for Bionpharma to market its generic Etravirine tablets in the US, expanding patient access to a cost-effective HIV treatment option.

USFDA Approval | 14/01/2026 | By News Bureau

Biocon Receives US FDA Approval for Everolimus Tablets for Oral Suspension

Biocon has secured US FDA approval for Everolimus Tablets for Oral Suspension, enhancing its portfolio of vertically integrated drug products and expanding treatment options for patients in key markets.

USFDA Approval | 13/01/2026 | By News Bureau

US FDA Grants Orphan Drug Designation to CK0804 Treg Therapy of Cellenkos

The US FDA has granted Orphan Drug Designation to Cellenkos’ CK0804, a first-in-class CXCR4hi Treg therapy for myelofibrosis. The investigational therapy is designed to home to the bone marrow and spleen, where it modulates inflammation through in-vivo expansion and IL-10 secretion.

USFDA Approval | 07/01/2026 | By News Bureau

Novo Nordisk Introduces Wegovy Pill with knownwell as NovoCare Provider

Novo Nordisk has launched Wegovy in an oral pill form, marking the first FDA-approved oral GLP-1 therapy, with knownwell recognised as a NovoCare provider to support broader patient access to clinician-led metabolic care across the US.

USFDA Approval | 06/01/2026 | By News Bureau

ScinoPharm Wins FDA Approval for Glatiramer Acetate Injection

ScinoPharm Taiwan has received US FDA approval for its Glatiramer Acetate Injection for the treatment of multiple sclerosis, marking a significant milestone as the first and only Taiwanese pharmaceutical company to secure FDA approval for this complex generic, and reinforcing Taiwan’s growing role in the global pharmaceutical supply chain.

USFDA Approval | 05/01/2026 | By News Bureau

Vanda Pharma Wins FDA Approval for NEREUS to Prevent Motion Induced Vomiting

Vanda Pharmaceuticals has received FDA approval for NEREUS (tradipitant) to prevent motion-induced vomiting, marking the first new pharmacologic treatment for motion sickness in more than four decades and a significant advance in managing a condition that affects a large segment of the population and impacts military operational readiness.

USFDA Approval | 31/12/2025 | By News Bureau |  133

US FDA Approves Agios' AQVESME for Thalassemia-Related Anaemia

The US FDA has approved Agios’ AQVESME for the treatment of anaemia in adults with thalassemia, making it the only approved therapy for both transfusion-dependent and non-transfusion-dependent patients. The drug will be marketed in the US under the AQVESME brand for thalassemia, with availability expected in late January 2026.

USFDA Approval | 24/12/2025 | By News Bureau

Amneal Gains US FDA Approval for Prolia and XGEVA Denosumab Biosimilars

The US FDA approvals for Prolia and XGEVA denosumab biosimilars strengthen Amneal’s growing biosimilars portfolio, with the company planning to commercialise six biosimilars across eight presentations by 2027.

USFDA Approval | 23/12/2025 | By News Bureau |  117

US FDA Approves Wegovy by Novo Nordisk as first Oral GLP-1 for Weight Loss

Wegovy’s approval is supported by phase III OASIS 4 trial data showing a mean weight loss of 16.6 percent, with the oral GLP-1 indicated for long-term weight management and reduction of major adverse cardiovascular events, and Novo Nordisk planning a US launch in early January 2026.

USFDA Approval | 23/12/2025 | By News Bureau |  168