Merck wins FDA priority review for KEYTRUDA bladder cancer combo expansion

If approved, the move would significantly broaden the use of KEYTRUDA and KEYTRUDA QLEX in combination with Padcev

Roche’s MS drug fenebrutinib delivers striking Phase III results by cutting relapse rates by 58%

The company announced that its Phase III FENhance 1 and 2 studies both met their primary endpoints

CDSCO rolls out prior intimation system to fast-track drug testing and R&D

Shift from approvals to digital intimation via NSWS portal aims to cut timelines and boost innovation in early-stage drug development

Strengthening India’s pharma brand through compliance-first manufacturing: Vijay Kumar Aggarwal, MD, Medicef Pharma

By prioritising absolute compliance, leveraging the power of digital tools, and aligning with government policies, the sector is locking in its future leadership

Precision BioSciences expands Hepatitis B gene editing trial into France and Romania

The Clinical Trial Application (CTA) approval clears the way for the company to launch trial locations in France and Romania

Aurobindo Pharma bags USFDA nod for Glycerol Phenylbutyrate Oral Liquid

The approved product is a generic version of Ravicti, originally developed and marketed by Horizon Therapeutics

Loopworm’s silkworm-based ingredients found carbon negative in PwC-backed study

The study was conducted by PwC India in line with ISO 14040 and ISO 14044 protocols

Aurobindo Pharma wins key FDA nod for $138M US cough drug market entry

The drug is designed to provide temporary relief from cough caused by throat and bronchial irritation

Aurobindo Pharma wins USFDA nod for rare disease drug set for immediate launch

Philips wins FDA nod for AI-powered spectral CT system Verida

At the core of Verida is Spectral Precise Image technology paired with a third-generation Nano-panel Precise dual-layer detector and an AI-based deep learning reconstruction engine