Health & Biotech

Drug approvals, clinical trials, biotechnology, medical research, public-health developments and regulatory decisions.

  1. The 8,323-person trial enrolled adults with established cardiovascular disease and Lp(a) levels of at least 70 mg/dL.

  2. The FDA’s decision applies to patients whose cancer progressed during or after platinum chemotherapy and anti-PD-(L)1 treatment.

  3. According to the study, medium-HDI countries had the largest estimated increase, at 61,863 additional heat-related deaths per year.

  4. Rhythm says the portfolio royalty will be 1% of worldwide net sales from January 2029, or earlier if bivamelagon launches commercially.

  5. The tentative status permits U.S. government procurement during the original product’s patent-protection period, but not U.S. commercial sales.

  6. FDA recommends combining manufacturing controls and testing throughout development and production, rather than relying on lot-release assays alone.

  7. The approval covers adults with active psoriatic arthritis; ILUMYA injections must be administered by a healthcare provider.

  8. The required confirmatory study must track surgery frequency for at least three years in adults and children with recurrent respiratory papillomatosis.

  9. Casgevy uses a patient’s blood-forming stem cells, edited outside the body with CRISPR/Cas9 and returned by infusion.

  10. PRAC will assess the evidence and recommend whether the medicines’ national authorisations should remain unchanged, be amended, suspended or revoked.

  11. Paravalvular leaks let blood pass between a replacement valve and surrounding tissue; Paraclose is delivered by catheter to close the opening.

  12. The indication is for HRR-mutated metastatic disease; patients need an FDA-authorized test to identify qualifying mutations.

  13. The PASCAL indication covers eligible patients with severe, symptomatic tricuspid regurgitation despite optimal medical treatment.

  14. The phase 3 trial enrolled 455 patients in China with advanced nonsquamous lung cancer and PD-L1 scores below 1%.

  15. The global Phase III trial enrolled 594 patients with previously treated, CLDN18.2-positive gastric or related cancers.

  16. Genmab will conduct the proposed trial, and Incyte plans to share its funding and provide INCB161734.

  17. The phase 2a study enrolled 31 patients who could not receive or declined cisplatin-based chemotherapy.

  18. The phase 2 study enrolled 144 patients with resected pancreatic cancer and compared camupepimut with observation.

  19. The once-daily pellets are for prevention, not treatment of an acute hereditary angioedema attack.

  20. The FDA recommends quarantining affected procedure kits and removing recalled infusion sets; its October 20 alert says details remain under review.