Results from the study assisted Notal Vision in receiving De Novo authorization from the US FDA for the SCANLY Home OCT in ...

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced ...

Strong enrollment activity to start 2025146 patients enrolledTORONTO, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or ...

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to brelovitug (BJT-778) for the treatment of chronic hepatitis delta (CHD).

The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional ...

Breakthrough therapy designation recognises the potential of brelovitug to transform the lives of people living with CHD. We ...

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 ...

Bluejay Therapeutics, a clinical-stage biopharmaceutical company dedicated to developing potentially life-changing therapeutics for serious viral and liver diseases, today announced that ...

Trained on large databases of brain data among newborns, CergenX’s Wave device uses AI to help with earlier detection of ...

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 ...