China approves first-in-class TGCT drug, marking global first for pimicotinib

FDA grants breakthrough therapy designation to Enhertu for high-risk early breast cancer

This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care

FDA go-ahead to Roche’s one-minute follicular lymphoma therapy

Full approval will depend on verification of clinical benefit in a confirmatory trial

Zambon Biotech launches European Phase 3b trial for innovative Parkinson’s drug

The trial will evaluate the efficacy and safety of IPX203 versus immediate-release levodopa/carbidopa

FDA nod to MYQORZO for obstructive hypertrophic cardiomyopathy

The drug is designed to improve functional capacity and reduce symptoms by inhibiting cardiac myosin motor activity

Biocon Biologics expands FKB deal to secure global rights for Adalimumab biosimilar

Production at Biocon Biologics’ own facilities is scheduled to begin once technology transfers and regulatory approvals are finalized

TAKE Solutions plans AI-driven healthcare platform

The platform aims to serve doctors, consumers, and healthcare facilities by providing AI-assisted clinical decision tools, personalized health insights, and improved diagnostic capabilities

Altimmune’s Pemvidutide shows positive topline results from IMPACT Phase IIb trial

The therapy also drove additional weight loss at the higher 1.8 mg dose without plateauing and maintained a favorable tolerability profile

Ipsen’s FALKON trial falls short in rare FOP study, offers key insights

FOP is a rare genetic disorder caused by mutations in the ALK2 kinase

Abbott wins FDA & CE nod for groundbreaking premature infant heart device

The system is intended for some of the tiniest patients—premature infants weighing as little as two pounds