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Results For "approval"

2612 News Found

ECI taps industry veteran Khalid Raja to drive strategic growth
People | April 22, 2026

ECI taps industry veteran Khalid Raja to drive strategic growth

Move comes amid rising regulatory pressures


US FDA okays Merck's new once-daily HIV pill
Drug Approval | April 22, 2026

US FDA okays Merck's new once-daily HIV pill

The newly approved pill combines 100 mg of doravirine with 0.25 mg of islatravir


Merck wins FDA priority review for KEYTRUDA bladder cancer combo expansion
Clinical Trials | April 22, 2026

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


CDSCO rolls out prior intimation system to fast-track drug testing and R&D
Drug Approval | April 21, 2026

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
Opinion | April 21, 2026

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
Biotech | April 20, 2026

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
Drug Approval | April 20, 2026

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


Aurobindo Pharma wins key FDA nod for $138M US cough drug market entry
Drug Approval | April 20, 2026

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


Philips wins FDA nod for AI-powered spectral CT system Verida
Medical Device | April 20, 2026

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