Roche’s AI-based kidney disease algorithm gains European certification

The new algorithm will be introduced as part of Roche’s CKD Algorithm Panelon thenavify Algorithm Suite

Evofem's SOLOSEC submitted for regulatory approval in the UAE

Marks first international filing for Evofem’s single-dose oral treatment

Amgen’s Phase III data supports FDA label expansion of Repatha

Repatha is now the first and only PCSK9 inhibitor to demonstrate significant reduction of cardiovascular events as both primary and secondary prevention

AstraZeneca Pharma India receives sale, distribution approval from CDSCO for Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder

Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder for concentrate for solution for infusion is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors

Supriya Lifescience’s Ambernath facility receives WHO GMP certification

With global certification in place, the Ambernath site expands Supriya’s footprint beyond APIs into high-margin formulations

Novartis to launch DTP platform for Cosentyx in US

Through the new DTP platform, Novartis will make Cosentyx available to patients at a price that reflects the average savings typically retained by insurers and pharmacy benefit managers

FDA grants De Novo classification to first needle-free, glucose sensor Biolinq Shine

DPIIT and Thermo Fisher Scientific launch BioVerse challenge to fast-track India’s biotech future

India currently hosts more than 10,075 biotech startups

AbbVie seeks FDA approval for Pivekimab Sunirine to treat rare, aggressive blood cancer

BPDCN is a challenging blood cancer with characteristics of both leukemia and lymphoma

Winrevair cuts risk of PAH progression by 76% in phase 3 Hyperion trial

Hyperion results presented at ERS 2025 and simultaneously published in the New England Journal of Medicine