The drugmaker presented Phase I data for the CD38xBCMAxCD3-directed trispecific at the International Myeloma Society meeting ...
Heidi Overton's FDA confirmation hearing was less about running the agency and more about navigating three political ...
Atebrioz gains US FDA approval for fibrodysplasia ossificans progressiva as the first oral therapy for the ultra-rare disease ...
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 ...
PhRMA, BIO and other industry groups are supporting the FDA's single-trial approval pathway, but warn its "highly persuasive" ...
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