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

Morepen Laboratories secures fourth consecutive USFDA ‘NIL 483’ inspection

Zero-observation outcomes strengthen global credibility and accelerate CDMO ambitions

FDA clears Travere’s FILSPARI for expanded use in rare kidney disease

FDA grants priority review to Daiichi Sankyo & Merck’s lung cancer drug application

The investigational therapy, ifinatamab deruxtecan, is a potential first-in-class B7-H3 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and jointly developed with Merck

FDA presses 2,200+ companies to fix missing clinical trial results

Move amid evidence of widespread reporting gaps

FDA fast-tracks Daiichi Sankyo & Merck lung cancer drug review

The FDA is also reviewing the application under its Real-Time Oncology Review (RTOR) program and Project Orbis