News about "USFDA approval"

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

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

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 |  100

Enhertu Secures US BTD Status in Early HER2-Positive Breast Cancer

The US FDA has granted Breakthrough Therapy Designation to Enhertu for use as post-neoadjuvant treatment in patients with HER2-positive early breast cancer, marking the tenth such designation for AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate, supported by phase III DESTINY-Breast05 trial results.

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

US FDA Approves Roche's Lunsumio VELO for Subcutaneous Use in Follicular Lymphoma

The US FDA has approved Roche’s Lunsumio VELO for subcutaneous use in Relapsed or Refractory Follicular Lymphoma, cutting administration time to about one minute and supported by strong complete response data in later-line patients.

USFDA Approval | 22/12/2025 | By News Bureau

Abbott Secures FDA Clearance and CE Nod for Amplatzer Piccolo Heart Device

Abbott has received US FDA clearance and CE Mark for its Amplatzer Piccolo Delivery System, the first device specifically designed to treat premature infants with Patent Ductus Arteriosus (PDA). The system enables precise placement of the Amplatzer Piccolo Occluder in infants, addressing a condition that affects around 20 percent of premature infants.

USFDA Approval | 19/12/2025 | By News Bureau

Novo Nordisk Seeks FDA Approval for CagriSema Weight-Loss Therapy

CagriSema 2.4 mg/2.4 mg is an investigational once-weekly injectable combining cagrilintide and semaglutide to target complementary obesity pathways. In the REDEFINE 1 phase III trial, patients with obesity or overweight achieved an average weight loss of 23 percent, reinforcing the company’s ongoing focus on innovation in obesity treatment.

USFDA Approval | 19/12/2025 | By News Bureau

Alembic Pharma Wins USFDA Approval for Travoprost Ophthalmic Solution

Alembic Pharmaceuticals has secured USFDA approval for its Travoprost Ophthalmic Solution, with the ANDA deemed therapeutically equivalent to the reference listed drug Travatan Z (0.004%) from Sandoz.

USFDA Approval | 18/12/2025 | By News Bureau

FDA Qualifies PathAI's AIM-MASH as First AI Tool for MASH Clinical Trials

PathAI has achieved a regulatory milestone with the FDA qualifying its AIM-MASH AI Assist as the first AI-powered tool for MASH clinical trials. The qualification follows the EMA CHMP’s endorsement earlier this year, reinforcing PathAI’s leadership in advancing AI-driven histopathology solutions across American and European drug-development framework.

USFDA Approval | 10/12/2025 | By Akanki |  672