Saudi Arabia’s NADR rewrites rules for rare disease drug research with 20-day designation reviews and flexible evidence ...

Abbott is spinning off its $8.5bn nutrition business in 2027 with roughly 1,700 infant-formula lawsuits still pending — and ...

A new FDA website on predetermined change control plans lists the 240 devices authorized with them so far, led by Medtronic ...

NAD found “fatal flaws” in three studies Oral Essentials submitted in second review of “30 minutes to whiter teeth” claim it ...

ICER is planning to review Compass Pathways' psychedelic therapy for treatment-resistant depression after its review of Lykos ...

A cross-center program, which is part of HHS’s updated national dementia plan, will explore trial designs, endpoints and ...

Regulating the end-user output of prescription drug use-related software (PDURS) as labeling is consistent with the Food, ...

Leaked results slated for presentation at ESMO prompted debate about the neoantigen therapy’s applicability in other tumors and pushed both companies’ share prices lower, but the data impressed ...

Following a refuse-to-file letter and a complete response letter, Biohaven’s drug will be reviewed by the FDA for approval in ...

The European Parliament has approved the Omnibus VI package and the US FDA has finalized its mandatory cosmetic recall ...

New drugs are hitting the US market with staggering six-digit price tags, even as scrutiny on US drug prices versus prices in ...

Speaking at the MedTech Conference in Boston, CDRH director Michelle Tarver said the center authorized 151 novel devices in ...