STEERLife, the life sciences division of India-based STEER World, and Bionpharma Inc, a US-based pharmaceutical company, announced on Tuesday that Bionpharma has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its generic Etravirine tablets.
The product, a second-line antiretroviral therapy for the treatment of HIV/AIDS, was developed using STEERLife's proprietary FragMelt continuous processing platform which enables a sustainable, solvent-free manufacturing route while maintaining strict bioequivalence to the reference product, INTELENCE.
This approval enables Bionpharma to commercialise the product in the United States, expanding patient access to a high-quality, more affordable treatment option for HIV/AIDS.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Formation Bio acquires worldwide rights to FHND5032 from CTFH
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
Almirall receives China approval for Seysara to treat moderate-to-severe acne