FDA
Novo Nordisk says the FDA approved Awiqli (insulin icodec-abae) on March 26, 2026 — positioned as the first and only once-weekly, long-acting basal insulin for adults with type 2 diabetes, at 700 units/mL. The pitch is adherence math: cutting basal injections from seven to one per week for patients who struggle with daily routines. The approval is backed by the ONWARDS phase 3a program: four randomized, active-controlled, treat-to-target trials in roughly 2,680 adults with uncontrolled T2D, comparing once-weekly icodec to daily basal insulin and showing A1C reduction. The key implementation question now is real-world titration and safety monitoring — weekly dosing changes the cadence of both.
Source: BioSpace (PR Newswire)
Regulators
EMA’s CHMP published its March meeting highlights and recommended five medicines for approval: Adstiladrin (conditional; BCG-unresponsive NMIBC), Imdylltra (tarlatamab; relapsed extensive-stage SCLC), Joenja (leniolisib; APDS, estimated 1–2 per million incidence worldwide), Zepzelca (lurbinectedin; maintenance in extensive-stage SCLC), and Bopediat (furosemide; paediatric-use marketing authorisation). Two signals stand out for practice: a new reflection paper on a tailored clinical approach in biosimilar development (less clinical data for some biosimilars), and a referral conclusion recommending Tecovirimat SIGA should no longer be used for mpox.
Source: European Medicines Agency (EMA)
Cell & Gene
Fierce Biotech covers Nature Medicine data on EsoBiotec’s in vivo BCMA CAR-T candidate ESO‑T01 in a small Chinese phase 1 study in multiple myeloma. In five treated patients, four achieved objective responses and three reached stringent complete remission by day 60. The safety profile is the stress test: all patients had grade ≥3 adverse events; CRS occurred in four (grade 3 in three), and one patient died 19 days after dosing due to spinal cord compression linked to a lesion. The takeaway is less hype and more calibration: in vivo CAR-T may shift manufacturing friction, but it doesn’t magically erase CAR-T-class toxicities.
Source: Fierce Biotech