Ironwood Pharmaceuticals has been left considering its options after the FDA demanded another phase 3 trial before it will ...

Third Harmonic Bio has abandoned plans to take its chronic spontaneous urticaria (CSU) drug into phase 2, instead preparing ...

CTI grew from a Cincinnati startup to a global leader in clinical research. CEO Tim Schroder shares insights on its success ...

| Discover how AI and RWD are transforming drug development by optimizing clinical trial protocols, enhancing recruitment, ...

Pfizer has axed its oral GLP-1 asset danuglipron after one patient had potential drug-induced liver injury in a phase 1 trial ...

Verve Therapeutics has generated evidence its PCSK9 pivot could pay off. | Verve Therapeutics has generated evidence its ...

The White House has ordered the National Institutes of Health (NIH) to study "regret" among transgender people who have ...

The market turbulence unleashed by President Donald Trump’s tariff policies will likely evaporate the trickle of biotech IPOs ...

The FDA is moving away from requiring animal models for investigational new drug (IND) applications for new monoclonal ...

Dexcom has won a clearance from the FDA for its longest-lasting continuous glucose monitor, a 15-day version of its flagship ...

With its remote endovascular procedure system currently under review at the FDA, Microbot Medical has put forward positive ...

“Leadership in the agency’s been decapitated, and I think that was somewhat deliberate,” Janet Woodcock, M.D., former acting ...