AstraZeneca's fifth Ultomiris indication arrives on a proteinuria surrogate, while the week-106 eGFR readout still decides whether the drug actually saves kidneys.
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Wound care is becoming one of big medtech's next frontiers, and Swedish wound-care leader Mölnlycke just announced a separation into an independent wound-care company. At the center of that landscape sits MediWound (NASDAQ: MDWD).
Verastem's 900 mg KRAS G12D dose posted a 50% confirmed response rate in second-line pancreatic cancer, and the company will take a chemotherapy-free regimen into a first-line Phase 3. The rival comparison is overall survival.
With only about 5% of rare conditions carrying an FDA-approved treatment, the agency is trying to turn case-by-case flexibility into written, predictable defaults. Whether that produces certainty or new rigidity is the open question.
In depth
ArriVent's firmonertinib beat chemotherapy on investigator reads in a 398-patient Phase 3, but the blinded central review it chose returned p=0.0654, and first-line EGFR exon 20 lung cancer now belongs to combinations that keep chemotherapy in the regimen.
Read the storyLilly's once-weekly insulin Onswik is the second FDA approval in a six-month window, after Novo's Awiqli. Both won on non-inferiority data, leaving the real question open: whether weekly dosing actually improves insulin initiation and adherence.
BigHat Biosciences raised $75 million as BHB810, a CDH17 VHH-Fc ADC, entered a Phase 1/2 gastric cancer trial. The round tests whether wet-lab data can fix AI drug discovery's translation problem.
The FDA granted accelerated approval to AstraZeneca’s camizestrant based on ctDNA resistance signals before radiographic progression, overruling a 6-3 advisory committee vote and betting on a new oncology paradigm.
Conjugating antisense oligonucleotides to transferrin receptor transport vehicles achieves fifty-fold deeper brain penetration, challenging the standard of invasive spinal punctures.
