Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

FDA Approves Insmed’s New Oral Lung Di

USFDA has approved Insmed’s Brinsupri (Brensocatib) for Bronchiectasis, a chronic drug disease. The medicinal product

New NSCLC Drug Approved by USFDA –

China’s rise in cutting-edge pharmaceutical innovation received a major fillip with the USFDA approval of

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

The Father of Statins passes away: The L

The scientific community mourns the loss of Dr.Akiro Endo, whose death was announced by the

FDA clears Bovaer – Elanco’s Met

Elanco Animal Health announced that the USFDA has completed its comprehensive, multi-year review of Bovaer