Saudi Arabia’s NADR rewrites rules for rare disease drug research with 20-day designation reviews and flexible evidence ...
Following a refuse-to-file letter and a complete response letter, Biohaven’s drug will be reviewed by the FDA for approval in ...
NAD found “fatal flaws” in three studies Oral Essentials submitted in second review of “30 minutes to whiter teeth” claim it ...
A new FDA website on predetermined change control plans lists the 240 devices authorized with them so far, led by Medtronic ...
Abbott is spinning off its $8.5bn nutrition business in 2027 with roughly 1,700 infant-formula lawsuits still pending — and ...
Regulating the end-user output of prescription drug use-related software (PDURS) as labeling is consistent with the Food, ...
ICER is planning to review Compass Pathways' psychedelic therapy for treatment-resistant depression after its review of Lykos ...
Speaking at the MedTech Conference in Boston, CDRH director Michelle Tarver said the center authorized 151 novel devices in ...
The European Parliament has approved the Omnibus VI package and the US FDA has finalized its mandatory cosmetic recall ...
A cross-center program, which is part of HHS’s updated national dementia plan, will explore trial designs, endpoints and ...
New drugs are hitting the US market with staggering six-digit price tags, even as scrutiny on US drug prices versus prices in ...
A Phase III trial testing the IL-1α/1β antagonist lutikizumab in HS met the primary endpoint, but the placebo-adjusted ...
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