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Elevar, Hengrui Resubmit Liver Cancer Therapy Following 3rd Rejection
Elevar Therapeutics and China's Hengrui Pharmaceuticals have resubmitted a rivoceranib plus camrelizumab as a first-line treatment for patients with unresectable or metastatic hepatocellular carcinoma (HCC). The companies’ resubmission marks the fourth attempt to win U.S. approval, and follows three previous complete response letters (CRLs) issued in
Lawmakers Question Plan to Split MMR Vaccine
Congressional Democrats are questioning the Trump administration's proposal to replace combination childhood vaccines with separate injections, a policy that could require new FDA regulatory reviews because single-disease measles, mumps and rubella vaccines are not currently available in the U.S. In a 10/7 letter to CDC
Former FDA Official Questions Agency Role in Drug Pricing
Former FDA regulatory counsel and now-partner at Spencer Fane Brian Malkin is questioning whether the agency should become more directly involved in the Trump administration's drug-pricing initiatives, raising concerns about the potential direction of FDA policy under commissioner nominee Heidi Overton, whose nomination remains pending in
Rasonque OK’d Across KRAS Mutations Despite Clinical Response Differences
FDA granted approval to Revolution Medicines' Rasonque (daraxonrasib) for metastatic pancreatic cancer despite substantial differences in treatment responses among patients with different KRAS mutations and limited evidence of effectiveness in patients without RAS mutations, according to a newly released approval document. The 321-page review shows that FDA considered