While the complete response letter derails a near-term clearance, one analyst described the rejection as more of “a speed ...

Microsoft and our third-party vendors use cookies to store and access information such as unique IDs to deliver, maintain and ...

By 2023, the tone had shifted. Venture capital cooled. According to CB Insights, funding for AI drug discovery start-ups ...

Hartford Bakery recalls Lewis Bake Shop Artisan Style 1/2 Loaf bread from 12 states after consumer complaints about undeclared hazelnuts in the product.

Synchron, a top Neuralink competitor, rarely lets journalists visit its New York headquarters. What I saw there reveals the ...

Agriculture Secretary Brooke Rollins and Health and Human Services Secretary Robert F. Kennedy Jr. will hold a news briefing ...

Pune's Cafe Goodluck is in the limelight after its temporarily halted its operations. The Maharashtra FDA suspended the ...

The approval was supported by data from the randomized, double-blind, placebo-controlled, event-driven phase 3 FINEARTS-HF study.

Moderna’s COVID-19 vaccine has received full FDA approval for use in children at higher risk for severe illness.

Importantly, no serious safety concerns were reported in PATHFINDER 2. Detailed PATHFINDER 2 data are expected to be ...

The FDA approved a natural blue food dye amid a push to phase out synthetic additives. Here's what to know about gardenia (genipin) blue.

Many FDA accelerated approvals continue to rely heavily on surrogate endpoints, raising ongoing uncertainty about the true clinical benefits of these therapies.