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Treatment of adults with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test [2] Repotrectinib
In the US, fidanacogene elaparvovec is indicated for the treatment of adults with moderate to severe hemophilia B (congenital factor IX deficiency) who currently use factor IX prophylaxis therapy; or have current or historical life-threatening hemorrhage; or have repeated, serious spontaneous bleeding episodes; and do not have neutralizing antibodies to adeno-associated virus serotype Rh74var ...
A breakthrough therapy designation can be assigned to a drug if "it is a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition" and if the preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as ...
Experts share their advice on the steps you should take after you have a big realization or an "aha" moment during therapy.
In 2024, Science named lenacapavir "2024 Breakthrough of the Year", citing its "astonishing 100% efficacy" in one large efficacy trial in women and "99.9% efficacy in gender diverse people who have sex with men," while highlighting that research providing a "new understanding of the structure and function of HIV’s capsid protein" led to the ...
Nipocalimab is an experimental high affinity, fully human, aglycosylated, effectorless immunoglobulin G (IgG) anti-FcRn monoclonal antibody. [1]For hemolytic disease of the newborn (HDFN), nipocalimab works by decreasing levels of alloantibodies and other circulating IgG antibodies in the mother without impacting immune function.
The FDA grants breakthrough therapy status to Eli Lilly's (LLY) oral JAK inhibitor, Olumiant (baricitinib) for potential treatment of alopecia areata, an autoimmune disorder leading to hair loss.
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