FDA approval expands earlier use of Enhertu for metastatic breast cancer
The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with ...
clinicaladvisor.com3d
Brelovitug Granted Breakthrough Designation for Chronic Hepatitis Delta
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to brelovitug (BJT-778) for the treatment of chronic hepatitis delta (CHD).
Danaher’s Strategic Positioning and Breakthrough in Alzheimer’s Diagnostics Market Justifies Buy Rating
Leerink Partners analyst Puneet Souda has maintained their bullish stance on DHR stock, giving a Buy rating yesterday.Invest with Confidence: ...
JD Supra3d
CMS's New TCET Pathway Expedites Medicare Coverage for FDA Breakthrough Devices
The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional ...
GlobalData on MSN12d
FDA breakthrough status for Bluejay’s CHD therapy brelovitug
Breakthrough therapy designation recognises the potential of brelovitug to transform the lives of people living with CHD. We ...
Healio13d
Bluejay Therapeutics’ brelovitug secures FDA breakthrough status for chronic HDV
The FDA has granted breakthrough therapy designation to Bluejay Therapeutics’ brelovitug for the treatment of chronic hepatitis delta, for which no approved therapies currently exist in the U.S., the ...
The Bakersfield Californian13d
Bluejay Therapeutics Receives U.S. FDA Breakthrough Therapy Designation for Brelovitug ...
Bluejay Therapeutics, a clinical-stage biopharmaceutical company dedicated to developing potentially life-changing therapeutics for serious viral and liver diseases, today announced that ...
GlobalData on MSN14d
CergenX wins FDA breakthrough designation for neonatal EEG assessment tool
Trained on large databases of brain data among newborns, CergenX’s Wave device uses AI to help with earlier detection of ...
Yahoo Finance14d
CergenX wins FDA breakthrough designation for neonatal EEG assessment tool
The US Food and Drug Administration (FDA) has granted breakthrough device designation to CergenX’s AI-powered tool for neonatal brain scans. The Irish startup will now be in line for prioritised ...
Yahoo Finance17d
FDA grants breakthrough designation to PreludeDx’s DCIS test
The US Food and Drug Administration (FDA) has granted breakthrough device designation to PreludeDx's DCISionRT test, a risk assessment tool for ductal carcinoma in situ (DCIS), also known as Stage ...