Alembic announces USFDA tentative approval for Bosutinib tablets

Diabeloop bags FDA nod for DBLG2, opens US market for automated insulin delivery

The clearance marks a major step in Diabeloop’s ambition to become a central partner for insulin pump manufacturers and expand access to automated insulin delivery in the US market

Oculis’ Privosegtor wins FDA breakthrough therapy status for Optic Neuritis

The FDA designation follows visual-function results from the Phase 2 ACUITY trial

Granules Pharmaceuticals secures FDA tentative approval and 180-day exclusivity for Generic Dyanavel XR

This product has only one approved generic and one authorized generic with an addressable market share of US$ 172 million

Cellenkos scores FDA orphan drug designation for CK0804 in rare blood cancer

Receiving Orphan Drug Designation is an important milestone in the clinical development of CK0804 for myelofibrosis

Bayer’s Sevabertinib gets green light from FDA and China for advanced lung cancer

Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that directly targets HER2 mutations

Takeda & Protagonist submit FDA application for groundbreaking polycythemia vera therapy

The investigational subcutaneous hepcidin mimetic peptide is designed to regulate iron and red blood cell production

Stereotaxis scores FDA nod for groundbreaking MAGiC robotic heart catheter

The MAGiC catheter is designed for robotically-navigated cardiac ablation procedures

Ascletis Pharma gets FDA nod for Phase II diabetes trial of oral GLP-1 drug

The trial’s primary endpoint is the mean change in HbA1c from baseline, while secondary endpoints include changes in fasting blood glucose, body weight, and overall safety

FDA grants priority review to Tzield for youngest Type 1 diabetes patients

Currently approved for patients eight and older, Tzield could now be used to delay the onset of stage 3 type 1 diabetes (T1D) in children diagnosed with stage 2 T1D