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

Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection

The NDA submission follows the successful completion of a pivotal Phase III global clinical trial

FDA approves Roche’s Tecentriq + lurbinectedin as first-line maintenance therapy for lung cancer

Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase III IMforte study

FDA issues CRL for Sentynl’s copper histidinate for treatment of Menkes disease

AbbVie begins construction of $70 million biologics manufacturing site in US

The expansion will significantly enhance AbbVie’s ability to meet growing global demand for biologics, particularly in oncology and immunology

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

Pfizer agrees to slash prescription drug prices for Americans

Pfizer will participate in TrumpRx.gov, a direct-to-patient purchasing platform offering discount up to 85%

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

Biocon Biologics secures US market entry date for Bosaya and Aukelso, Denosumab biosimilars