News | February 05, 2026
AstraZeneca & Daiichi Sankyo gain priority review for Datroway in hard-to-treat breast cancer
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases
Currently approved for patients eight and older, Tzield could now be used to delay the onset of stage 3 type 1 diabetes (T1D) in children diagnosed with stage 2 T1D
ICC is a highly aggressive liver cancer arising from the intrahepatic biliary epithelium
The FDA aims to make a decision by April 8, 2026
Here's a development that aims to keep your blood pressure in check. Literally!
The submissions are supported by data from the Phase 3 KEYNOTE-905 trial
For patients with resectable early-stage gastric and gastroesophageal junction cancers
This is specifically for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition
Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure
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