IRLAB launches Phase Ib Trial of IRL757 for Parkinson’s patients with Apathy

The multicenter study will enroll 75 patients across 16 sites in Germany, Bulgaria, Poland, and Spain

FDA okays AQVESME as first treatment for anemia in alpha- & beta-thalassemia

The approval makes AQVESME the only FDA-approved therapy for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia

Biofabri and Bharat Biotech ink tech transfer pact to boost global TB vaccine access

BBIL will guarantee production and supply of MTBVAC to more than 70 countries across Africa and Southeast Asia

Cipla launches needle-free inhalable insulin Afrezza in India

Afrezza comes in single-use cartridges, delivered via a simple inhaler device. Users select the appropriate cartridge, load it, inhale the insulin, and remove the cartridge

Hansa Biopharma submits FDA application for kidney transplant desensitization treatment

If approved, imlifidase has the potential to transform the kidney transplant landscape by enabling highly sensitized patients to also have access to a potentially life-changing kidney transplant

Neurocrine’s Valbenazine fails to show benefit in largest dyskinetic cerebral palsy trial

Adverse events were consistent with valbenazine’s established safety profile

Bayer wins Japan nod for finerenone in broad heart failure population

Finerenone is the first therapy targeting the mineralocorticoid receptor pathway to demonstrate cardiovascular benefits in heart failure patients

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