B+L reports Lumify OTC eye drop sales growing 38% were a key revenue driver for its 7% overall Q3 growth to $1.38bn in the ...
The Oct. 30 advisory committee meeting will weigh the FDA’s concerns about the “fragility” of Sydnexis’ data for low-dose ...
Speaking at the MedTech Conference in Boston, CDRH director Michelle Tarver said the center authorized 151 novel devices in ...
NAD found “fatal flaws” in three studies Oral Essentials submitted in second review of “30 minutes to whiter teeth” claim it ...
Following a refuse-to-file letter and a complete response letter, Biohaven’s drug will be reviewed by the FDA for approval in ...
Efficacy among previously treated HR+/HER2- breast cancer patients looked in line with Merck/Kelun’s sac-TMT, but an analyst ...
NRx Pharmaceuticals has received a discipline review letter from the US Food and Drug Administration requesting "minor” ...
The UK wants to change the way medtech companies interact with its medical regulator via a more transparent process and ...
A white paper on “Digitally Derived Measures” stresses that the process of incorporating them into clinical trials must start ...
The European Parliament has approved the Omnibus VI package and the US FDA has finalized its mandatory cosmetic recall ...
Saudi Arabia’s NADR rewrites rules for rare disease drug research with 20-day designation reviews and flexible evidence ...
A new FDA website on predetermined change control plans lists the 240 devices authorized with them so far, led by Medtronic ...
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