The FDA's first dedicated guidance for robotically assisted surgical devices details submission requirements across 510(k), ...
The withdrawal of the hospital antibiotic means that Merck, once strongly committed to anti-infectives, has only mature ...
Atebrioz gains US FDA approval for fibrodysplasia ossificans progressiva as the first oral therapy for the ultra-rare disease ...
Heidi Overton's FDA confirmation hearing was less about running the agency and more about navigating three political ...
FDA Commissioner-nominee Heidi Overton walked the line between backing the Trump administration and prioritizing science ...
Sherafat, an eight-year agency veteran, is now acting director of the Office of Therapeutic Products’ Office of Clinical ...
The GDUFA IV commitment letter tackles two of the generic industry’s persistent concerns: facilities have had no direct line ...
PhRMA, BIO and other industry groups are supporting the FDA's single-trial approval pathway, but warn its "highly persuasive" ...
Can smaller markets in the EU rise to the top of launch plans by pharma companies as the US Most Favored Nation pricing ...
Oura is asking public markets to value a sleep-tracking ring at $16bn, with Eli Lilly and Dragoneer lined up as early buyers ...
Enveda, Basecamp Research and BigHat Biosciences raised $311m, $140m and $75m, respectively, showing investors remain ...
Among other executive moves is Bavarian Nordic recruiting a new CEO from Sanofi and Legend Biotech bringing in a new CEO from ...
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