FDA supports new ANDA prioritization pilot to support US generic drugs

Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection

The NDA submission follows the successful completion of a pivotal Phase III global clinical trial

Winrevair cuts risk of PAH progression by 76% in phase 3 Hyperion trial

Hyperion results presented at ERS 2025 and simultaneously published in the New England Journal of Medicine

Wockhardt submits drug application to FDA for Zidebactam-Cefepime for treatment of serious Gram-negative infections

This milestone marks the first-ever NDA submission to the U.S. FDA for a drug, fully discovered and developed by an Indian pharmaceutical company

Revvity launches AI-powered software to transform preclinical imaging analysis

The platform integrates artificial intelligence into a unified environment that supports optical, microCT, ultrasound, and other imaging modalities

Moderna’s mNEXSPIKE generates strong immune response against LP.8.1 variant in humans

Both of Moderna's COVID-19 vaccines for the 2025-2026 season have demonstrated strong immune responses against today's top circulating COVID-19 strains

DMMA warns regulatory burden threatening Gujarat’s pharma MSMEs

The association called for an end to the constant issuance of regulatory circulars that make operations unpredictable and capital-intensive.

Max Hospital, Saket pioneers India’s first HDF certification program for Nephrologists

Pharma Manufacturing & Automation Convention 2025 to be held on Oct. 8-9, 2025 in Hyderabad

Sessions will cover process mapping, cost optimisation, data-driven decision-making, cybersecurity, and sustainable manufacturing practices

FDA responds to evidence of possible association between autism and acetaminophen use during pregnancy

Agency initiates safety label change and notifies physicians of possible link