FDA grants breakthrough therapy designation to R-DXd for platinum-resistant ovarian and related cancers

Raludotatug deruxtecan is a specifically engineered, potential first-in-class CDH6-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo

FDA launches crackdown on deceptive drug advertising

The FDA is beginning rulemaking to close the “adequate provision” loophole

Biocon inaugurates first US manufacturing facility in New Jersey

Sirio secures TGA GMP certification to support strategic growth in Australia

The Ma’anshan site approval covers pastilles, oral liquids, and powders

Parexel appoints Jim Anthony as CCO and President, Parexel Biotech

Anthony brings more than 25 years of pharmaceutical development and CRO experience to his expanded role

From Policy to Practice: How India’s Pharmaceutical Industry is Being Shaped by the PLI Scheme – by Vikram Aditya Sehgal, Director – Finance, Centrient India

The PLI scheme focuses on incentivizing a strategic shift towards high-value, innovative products such as biologics, complex generics, and specialty formulations

Sandoz to acquire Just–Evotec Biologics facility for $300 million

The companies will now begin detailed contract negotiations and proceed with necessary consultations and approval processes

Milestone Pharmaceuticals announces FDA acceptance of response to Cardamyst nasal spray CRL

Milestone also announced the extension of its $75 million Royalty Purchase Agreement with RTW Investments

Lilly partners with API to launch ‘Obesity Gurukul’ in India

The program will offer a structured and immersive learning experience for over 20,000 healthcare professionals across more than 10 cities

Merck to initiate Phase 3 trials for investigational once-monthly HIV prevention pill

In collaboration with the Gates Foundation, Merck advances MK-8527 pre-exposure prophylaxis (PrEP) clinical trials globally