AstraZeneca wins US nod for at-home lupus treatment in major shift for SLE care

The approval was driven by data from the Phase III TULIP-SC trial

Cipla wins USFDA nod for first generic of Ventolin HFA strengthening respiratory push

The approval makes Cipla’s product the first AB-rated generic therapeutic equivalent of Ventolin HFA

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

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

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

Briefs: Indoco Remedies and Panacea Biotec

Panacea Biotec receives LoA from CMSS

Gennova CEO Dr Sanjay Singh sees strong innovation momentum for India’s biopharma sector

Veteran biopharma leader stressed that generic medicines must be viewed separately from biologics

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