Granules India’s facility secures FDA EIR with 'VAI’
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025
Key secondary endpoints also demonstrated statistically significant and clinically meaningful benefits with Gazyva
Sotyktu continues to demonstrate consistent efficacy and safety across rheumatic conditions
This approval marks a significant milestone in women’s health, introducing Bayer’s first hormone-free treatment for menopause-related symptoms
The Fast Track Designation was supported by nonclinical data as well as clinical results from the ongoing Phase I/IIa trial evaluating the safety and tolerability
Medherant’s testosterone TEPI Patch could become the first-in-class testosterone patch developed specifically for women
Ticagrelor tablets are indicated for reducing the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients
The new CMC Process R&D Center represents a strategic investment in scale, sustainability, and specialization
It will produce a comprehensive range of dosage forms including tablets, hard gelatin capsules, liquids, injectables, topicals, and beta-lactam products
Subscribe To Our Newsletter & Stay Updated