Pharma

Sofe‑M plus bevacizumab produced a 79% confirmed objective response rate and 100% disease control in platinum‑sensitive ovarian cancer, with activity across FRα levels and prior PARPi exposure.

Interim Phase III DASL-HiCaP results show darolutamide added to ADT and radiation significantly improves metastasis-free survival versus placebo in high‑risk patients.

Apalutamide plus short-course ADT given six months around prostatectomy improved event-free and metastasis-free survival and delayed need for additional therapy in a 408‑patient randomized substudy.

Phase 3 DeLLphi‑305: IMDELLTRA with durvalumab raised median OS to 21.1 vs 12.7 months, tripled PFS, and produced ~80% one‑year survival versus 53%.

76% of evaluable patients had no detectable cancer after dostarlimab monotherapy; responders show no recurrences after more than two years; safety consistent with known profile.

Phase 1/2 trial will combine an EGFR/LGR5 bispecific antibody with a KRAS G12D inhibitor plus chemotherapy as first‑line treatment for KRAS G12D‑mutant metastatic colorectal cancer.

Phase 3 RAINFOL‑02 shows statistically significant and clinically meaningful PFS and OS benefits versus investigator’s choice chemotherapy in platinum‑resistant ovarian cancer.

Phase III data show once‑monthly ASO sefaxersen reduced proteinuria versus placebo at 37 weeks in adults with IgA nephropathy, with consistent subgroup effects and no new safety signals.

Guidance to help start Bundibugyo virus vaccine trials rapidly while maintaining safety: allows some animal-study waivers for known platforms, recommends early African trials, single-dose preference, and ring trial design.

Reduces basal injections from seven to one per week; insulin icodec‑abae is U‑700, indicated for ages ≥10, supported by pediatric PK and ONWARDS clinical data.