FDA grants breakthrough therapy designation to Ifinatamab Deruxtecan for lung cancer patients

Fourteenth breakthrough therapy designation granted by FDA across the oncology portfolio of Daiichi Sankyo

Xspray Pharma licenses patent rights to Handa Therapeutics, secures royalty agreement

Its lead product, Dasynoc, is awaiting FDA approval with a PDUFA date of October 7, 2025

AN2 Therapeutics begins first-in-human trial of oral AN2-502998 for chagas disease

Phase 1 dosing is expected to finish by the end of 2025

Enable injections receives enFuse system approval in Brazil and UK registration

AbbVie to invest $195 million to expand API manufacturing in North Chicago

The new facility will enhance AbbVie’s chemical synthesis capacity to support domestic production of current and next-generation neuroscience, immunology, and oncology medicines

AAVantgarde Bio receives FDA fast track designation for AAVB-039 in stargardt disease

The therapy delivers the full-length ABCA4 protein and has the potential to benefit all patients with ABCA4 mutations

Eight Roads Ventures to host fourth edition of Scale-Up Health conference on Sept 10

The conference will explore the path to India’s first billion-dollar drug, evolution towards value-based healthcare, biotech breakthroughs, and the role of AI and LLMs in care delivery

Indoco Remedies receives final USFDA approval for rivaroxaban tablets

Rivaroxaban is used to treat venous thromboembolism

Senores Pharmaceuticals acquires ANDAs from Teva Pharmaceuticals USA

The acquired ANDAs represent a market opportunity of about US$ 38 million in the USA

Zydus Lifesciences reports Q1 FY26 net profit at Rs. 1,466.8 Cr

The company reported revenue from operations at Rs. 6,573.7 crore, up 6 per cent YoY