KalVista Pharmaceuticals brings to Chiesi Group the product Ekterly, the first FDA-approved oral drug for acute treatment of swelling attacks from the rare disease hereditary angioedema. Ekterly’s tablet formulation offers a dosing edge compared to injectable HAE medications.

The post Chiesi Group Grows Again in Rare Disease With $1.9B KalVista Acquisition appeared first on MedCity News.

KalVista Pharmaceuticals’ Ekterly is now FDA approved for treating acute swelling attacks from hereditary angioedema. The KalVista tablet provides an alternative to injectable or infused HAE medications from companies such as Takeda Pharmaceutical and CSL Behring.

The post KalVista Drug Gets FDA Approval for Treating Acute Swelling Attacks From Rare Disease appeared first on MedCity News.

The FDA placed a clinical hold on a KalVista Pharmaceuticals drug being readied for mid-stage studies in a rare, inherited disorder. Meanwhile, the FDA has some questions about the historical data Y-mAbs used as the control in a clinical trial for its antibody cancer drug.

The post Regulatory progress for two biotechs stalls as FDA requests more information appeared first on MedCity News.

One year after losing Merck as a partner, KalVista reports mid-stage clinical data for a pill that could offer an alternative to injectable drugs for a rare, potentially life-threatening disease. KalVista plans to meet with the FDA about proceeding to a Phase 3 study.

The post KalVista Pharma plans pivotal test after HAE drug posts positive Phase 2 data appeared first on MedCity News.