Yale and Har­vard med­ical school fac­ul­ty are ques­tion­ing whether the FDA and Amer­i­can com­pa­nies will ac­tu­al­ly ben­e­fit from the US-fo­cused in­cen­tives in the next user...

The FDA’s long-await­ed ex­pe­dit­ed in­ves­ti­ga­tion­al new drug pi­lot pro­gram be­gan ac­cept­ing ap­pli­ca­tions Tues­day, with top agency of­fi­cials in­cor­po­rat­ing pub­lic feed­back in­to who should qual­i­fy.

Karim...

As more rare dis­ease treat­ments make their way to the FDA, the agency on Mon­day called for fur­ther out­side in­put as it grap­ples with how...

Top HHS of­fi­cial Chris Klomp had a rel­a­tive­ly mild nom­i­na­tion hear­ing with sen­a­tors on Tues­day, but he sparred with Sen. Eliz­a­beth War­ren (D-MA) over vol­un­tary...

As the FDA ramps up its ef­fort to ac­cel­er­ate the de­vel­op­ment of psy­che­del­ic ther­a­pies, men­tal health ex­perts on Mon­day urged the agency to con­sid­er cer­tain...

Schol­ar Rock has won FDA ap­proval for its drug treat­ing a rare mus­cle-wast­ing dis­ease, af­ter fac­ing de­lays due to a trou­bled man­u­fac­tur­ing fac­to­ry.

The in­jectable...