In an untitled letter issued last Friday and made public this week, the FDA took aim at clinical data included on a doctor-facing web page for Taiho Oncology’s Lytgobi.

Late Tuesday, the Senate confirmed Johns Hopkins surgeon Marty Makary, M.D., as the FDA’s new commissioner in a 56-44 vote, which saw all Republicans and three Democrats back the Trump administration’s nominee. Makary’s confirmation overlaps with that of Stanford University’s Jay Bhattacharya, M.D., Ph.D., who was also voted in by the Senate 53-47 to head up the National Institutes of Health this week.

J&J has the most convincing data that its combination of Rybrevant and Lazcluze could replace AstraZeneca’s Tagrisso as the new standard of care in first-line EGFR-mutated lung cancer—proof it could extend patients’ lives.

The series E round follows the launch of Supira's U.S. feasibility study, which recently enrolled 15 participants undergoing high-risk PCI.

Acrivon Therapeutics is halting work on developing its lead drug for ovarian and bladder cancers, instead focusing the Eli Lilly castoff solely on endometrial cancer.

The FDA has approved Exelixis’ Cabometyx for neuroendocrine tumors. In an interesting item in the drug’s updated label, the FDA acknowledges the potential impact that control arm patient crossovers may have had on patient survival results.

ATyr Pharma is stepping up its preparations to launch a steroid-sparing drug with the appointment of a commercial head who previously helped ChemoCentryx communicate a similar value proposition en route to its acquisition by Amgen.

Newronika's AlphaDBS system continuously adjusts its output based on real-time brain signals, instead of the conventional fixed-stimulation doses.