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

Shares of several biotech firms fell in premarket trading Monday after reports that ousted U.S. Food and Drug Administration vaccine regulator Vinay Prasad will return to the agency.

Eli Lilly’s orforglipron cut body weight to a lesser extent than rival Novo Nordisk’s semaglutide, falling into analysts’ ...

Net loss per share (GAAP) was $0.62, but remained negative as the company continues to invest heavily in research and development. The pivotal Phase 2 trial for Danon disease was placed on clinical ...

FDA approval of IBTROZI (taletrectinib) transformed Nuvation Bio into a commercial-stage company, driving $4.8 million in GAAP revenue, well above GAAP revenue estimates. Earnings per share (GAAP) was ...

Discover how AVA brings scale and reproducibility to organ‑chip technology, enabling human‑relevant insights that accelerate ...

Adjusted EBITDA (Q4): Adjusted EBITDA loss of $316,000 for Q4 FY2025, substantially narrowed from a $1.7 million adjusted ...

A controversial hematologist-oncologist who joined FDA this spring and quickly became its top regulator has left the ...

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

WASHINGTON -- The Food and Drug Administration on Monday named a longtime pharmaceutical executive to run the agency's drug program, the latest in a string of leadership changes at the agency. FDA ...

The FDA on Monday named a longtime pharmaceutical executive to run the agency's drug program, the latest in a string of leadership changes at the agency. FDA Commissioner Marty Makary, MD, MPH, ...