HC Wainwright & Co. analyst Mitchell S. Kapoor reiterates Neurogene (NASDAQ:NGNE) with a Buy and maintains $45 price tar...

Completed discussions with FDA on registrational protocol; 13 sites to allow for rapid enrollmentNew preclinical data at ESGCT ...

The SPDR S&P Biotech ETF (ARCA:XBI) is up more than 40% over the past six months and is on the verge of breaking out. Here...

FDA launches Rare Disease Evidence Principles to guide therapy reviews, offering new pathways for approval while raising questi...

Vinay Prasad returns as FDA's CBER director after brief exit, raising questions on rare disease drug approvals and mRNA vac...

Vinay Prasad exits FDA's biologics division following pressure over Sarepta's Elevidys approval and regulatory controve...