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

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

Astellas & Pfizer win FDA priority review for bladder cancer treatment expansion

A decision is expected by August 17, 2026 under the Prescription Drug User Fee Act timeline

Supriya Lifescience receives USFDA EIR with VAI classification for Maharashtra API facility

Inspection outcome reinforces company's compliance track record and strengthens its ability to serve regulated markets including the United States

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

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

FDA pushes forward on gene-editing therapies with new safety roadmap

Genome editing holds extraordinary promise for treating previously incurable genetic diseases

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

Cipla receives two observations following USFDA inspection at Goa facility

The company stated that it will work closely with the regulator to address the observations within the stipulated timeframe