Regulatory

Travere Therapeutics’ Filspari (sparsentan) Receives the US FDA’s Full Approval for Treating IgA Nephropathy

Travere Therapeutics’ Filspari (sparsentan) Receives the US FDA’s Full Approval for Treating IgA Nephropathy

Shots: The US FDA has granted full approval to Filspari (400mg) for treating IgAN,...

Lisata Therapeutics’ Certepetide Granted FDA Orphan Drug Designation for the Treatment of Cholangiocarcinoma

Lisata Therapeutics’ Certepetide Granted FDA Orphan Drug Designation for the Treatment of Cholangiocarcinoma

Shots: The US FDA has granted orphan drug designation to the company’s certe...

Vivet Therapeutics’ VTX-806 Receives the EC’s Orphan Drug Designation for Cerebrotendinous Xanthomatosis (CTX)

Vivet Therapeutics’ VTX-806 Receives the EC’s Orphan Drug Designation for Cerebrotendinous Xanthomatosis (CTX)

Shots: The EC has granted orphan drug designation to VTX-806, an adeno-associated...

KalVista Reports the US FDA’s NDA Acceptance of Sebetralstat for Treating Hereditary Angioedema (HAE)

KalVista Reports the US FDA’s NDA Acceptance of Sebetralstat for Treating Hereditary Angioedema (HAE)

Shots: The US FDA has accepted NDA for sebetralstat to treat HAE (PDUFA: Jun 17, 2...

Grit Biotechnology Reports the US FDA’s IND Approval of GT201 for Treating Advanced Solid Tumors

Grit Biotechnology Reports the US FDA’s IND Approval of GT201 for Treating Advanced Solid Tumors

Shots: The US FDA has granted clearance to the company’s IND application for...

Pierre Fabre Laboratories Reports the EC’s Approval of Braftovi Plus Mektovi to Treat Advanced Non-Small Cell Lung Cancer

Pierre Fabre Laboratories Reports the EC’s Approval of Braftovi Plus Mektovi to Treat Advanced Non-Small Cell Lung Cancer

Shots: The EC has approved Braftovi + Mektovi to treat advanced NSCLC adults with...

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