The U.S. Department of Health and Human Services has tapped Sean Keveney for the job of FDA chief counsel, but the recent history of the position muddies the waters when it comes to HHS oversight of FDA legal affairs.

The U.S. FDA has staked out a position on the use of per- and polyfluoroalkyl substances in medical devices, declaring that the evidence offers no reason to restrict their continued use in med-tech products.

Jazz Pharmaceuticals plc is prepped and ready for launch following U.S. FDA accelerated approval of dordaviprone as the first systemic therapy for H3 K27M-mutant diffuse glioma. Branded Modeyso, the orally administered first-in-class imipridone was acquired via Jazz’s acquisition earlier this year of Chimerix Inc. in a deal valued at about $935 million.

Cancel culture continues at the U.S. Department of Health and Human Services (HHS) as it observes National Immunization Awareness Month with another strike against vaccines. This time, a $500 million strike specifically targets 22 mRNA vaccine R&D programs at the Biomedical Advanced Research and Development Authority (BARDA), marking the beginning of the end of BARDA’s funding for mRNA vaccines.

Alcon AG agreed to acquire Staar Surgical Co. in a $1.5 billion cash transaction that would add Staar’s Evo implantable Collamer lenses (ICL) to treat myopia to the vision giant’s portfolio. Alcon will pay $28 per share, a 59% premium on Staar’s 90-day volume-weighted average price and a 51% premium on the Aug. 4 closing price of its shares (Nasdaq: STAA).

The U.S. Centers for Medicare & Medicaid Services adopted several significant policy changes in the Medicare inpatient final rule for fiscal 2026, which includes a larger rate bump for hospitals than seen in the draft.

Olympus Corp.’s “active investment” in endoluminal robotics has materialized in a new joint venture med-tech called Swan Endosurgical Inc., with Revival Healthcare Capital LLC.

Alterity Therapeutics Ltd. helped develop a new neuroimaging biomarker called the multiple system atrophy index (MSA-AI), which looks to be a more reliable biomarker for tracking disease progression of MSA.

While U.S. President Donald Trump’s country-by-country reciprocal and newly negotiated tariffs go into effect today, a separate, global biopharma sector tariff of, possibly, 200% continues to loom over the sector. For many stakeholders, a biopharma sector tariff of even 25%, as first proposed by Trump, would be a disaster in the making, especially when combined with the pressures of Medicare price negotiations and the president’s escalation of most-favored-nation pricing.