Category: Product Approval

FDA Approves Sanofi’s New Hemophilia 

The U.S. Food and Drug Administration (FDA) has approved Sanofi’s Qfitlia (fitusiran) for the treatment

FDA Approves New Skin Cancer Drug

USFDA has approved Checkpoint Therapeutics Cosibelimab-ipdl (Unloxcyt) for treatment of skin cancer CSCC (metastatic cutaneous squamous

FDA Approves New Drug for Control of And

The USFDA has approved Neurocrine Biosciences’ new drug, Crenessity (Crinecerfont), for the treatment of classic

FDA approves Roche’s Inavolisib fo

USFDA has approved Inavolisib ((Itovebi) of Genentech in combination with palbociclib and fulvestrant, for the

FDA Approves New Molecular Entity Lazert

FDA has given approval for Janssen’s New Molecular Entity Lazertinib (Lazcluze). Approval is accorded for

FDA approves Gileads Liver Drug Livdelzi

Gilead announced FDAs approval of Livdelzi (Seladelpar) for treatment of PBC, a rare, chronic, autoimmune

FDA approves Akebia’s Vafseo (Vadadust

FDA approved Akebia’s Vafseo (Vadadustat) for treatment of anaemia due to Chronic Kidney Disease (CKD)

FDA approves Merck’s Winrevair (Sotate

FDA has approved Merck’s Biologic drug Winrevair (Sotatercept-CSRK) for Pulmonary Arterial Hypertension (PAH). The product

USFDA Approves Duvyzat for Muscular Dyst

USFDA has approved Italfarmaco’s Duvyzat (givinostat) oral medication for treatment of Duchenne Muscular Dystrophy (DMD).

USFDA approves Idorsia’s Tryvio (Aproc

USFDA has approved Idorsia’s new drug Tryvio, a New Molecular Entity (NME) drug Aprocitentan for