Drug Approval | September 02, 2025
FDA approves Sanofi’s BTK inhibitor for immune thrombocytopenia
ITP is a disease of complex immune dysregulation leading to low platelet counts, bleeding, and reduced quality of life
ITP is a disease of complex immune dysregulation leading to low platelet counts, bleeding, and reduced quality of life
Glenmark’s Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials is bioequivalent and therapeutically equivalent to the reference listed drug, Halaven Injection, 1 mg/2 mL (0.5 mg/mL),of Eisai
Facility designed to advance the next generation of imaging systems
First Indian company to follow global recommendations in accordance with the World Health Organisation (WHO)
The positive benefit-risk profile of vericiguat in its approved indication in patients with HFrEF following a recent heart failure event based on the pivotal Phase III VICTORIA trial remains unchanged
Zilebesiran, a potential best-in-disease RNAi anti-hypertensive with twice-yearly subcutaneous dosing, demonstrated encouraging safety when combined with two or more antihypertensives
At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported
The sudden subsequent decision to suspend IXCHIQ is based on updated VAERS data
Nuvaxovid is the only protein-based, non-mRNA COVID-19 vaccine available in the U.S. for the 2025-2026 vaccination season
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