FDA Rules on Lung Cancer Bispecific Today; Sickle Cell Drug Filed

Busy days in medicine: the FDA has until midnight to rule on a first-in-class bispecific antibody for lung cancer, Novo Nordisk has filed what could be a transformative new option for sickle cell disease, and two ongoing outbreaks — Ebola in Central Africa and diphtheria in Senegal — continue to widen.

Friday, 14 November: FDA Reaches Decision Day on Ivonescimab in EGFR-Mutant Lung Cancer

Today is the PDUFA target date for the FDA's review of ivonescimab (Summit Therapeutics), a first-in-class bispecific antibody that simultaneously blocks both the PD-1 immune checkpoint and VEGF, a protein that tumours exploit to build new blood vessels. The FDA is considering a Biologics License Application for ivonescimab combined with platinum-based chemotherapy in patients with EGFR-mutated, non-squamous non-small-cell lung cancer (NSCLC) whose disease progressed after treatment with a tyrosine kinase inhibitor — a population with limited options once targeted therapy fails. The application is based on the Phase 3 HARMONi trial. Ivonescimab is already approved in China; a US approval would make it the first PD-1/VEGF bispecific authorised in the country and Summit's inaugural marketed product. The FDA had not announced a decision as of this article's publication.

Thursday, 13 November: Novo Nordisk Files Etavopivat for Sickle Cell Disease with FDA and EMA

Novo Nordisk submitted regulatory applications to the US Food and Drug Administration and the European Medicines Agency for etavopivat, a once-daily oral pyruvate kinase activator being developed for adolescents and adults with sickle cell disease (SCD). The filing is based on data from the Phase 3 HIBISCUS trial, which enrolled patients with SCD on a background of standard care. The trial met both co-primary endpoints: patients receiving etavopivat experienced 27% fewer vaso-occlusive crises — episodes of severe, often hospitalising pain caused by sickled cells obstructing blood vessels — compared with placebo, and 48.7% achieved a haemoglobin response of 1 g/dL or greater at week 24, versus 7.2% on placebo. Etavopivat holds FDA Fast Track, Rare Pediatric Disease, and Orphan Drug designations; Novo originally acquired it through its $1.1 billion buyout of Forma Therapeutics in 2022. If approved, it would offer a new oral option alongside existing injectable therapies and the newer gene-therapy approaches for SCD.

Wednesday, 12 November: FDA Clears US Trial for Cyclarity's Atherosclerosis Drug UDP-003

Cyclarity Therapeutics received FDA Investigational New Drug clearance for UDP-003, its lead programme targeting a form of oxidised cholesterol — 7-ketocholesterol — that accumulates in the arterial plaque macrophages that drive coronary artery disease and is not addressed by statins or PCSK9 inhibitors. The IND clearance lets Cyclarity expand its ongoing Phase 1b study, so far run outside the US, into American centres; enrolment is expected to open in Q1 2027. UDP-003 is a cyclodextrin-based molecule designed to selectively extract 7-ketocholesterol from plaque, an approach that has reversed plaque formation in preclinical models. This is a dose-finding phase: no efficacy data in humans have yet been published, and results are several years away.

Monday, 10 November: US Extends Ebola Travel Attestation; Outbreak Reaches 11,145 Cases

The US Centers for Disease Control and Prevention issued a 30-day extension of its public health order on 10 November, requiring all international air passengers to attest they have not been in the Democratic Republic of the Congo in the preceding 21 days before boarding a US-bound flight. The measure — first imposed on 3 November — reflects the continued growth of the Bundibugyo-strain Ebola outbreak, which CDC now counts at 11,145 confirmed cases and 5,437 confirmed deaths as of 10 November. The World Health Organization has classified the outbreak as a Public Health Emergency of International Concern, with active transmission in 51 health zones across eight DRC provinces. Kenya has confirmed nine cases, all linked to travel from the DRC; six have recovered and no new cases have been reported recently. No US cases have been confirmed.

Ongoing: Senegal's Diphtheria Outbreak Spreads to 13 Regions

Senegal's Ministry of Health had recorded 456 confirmed diphtheria cases and 14 deaths across 13 of the country's 14 regions as of 1 November, since the outbreak began in July 2026. The European Centre for Disease Prevention and Control is monitoring a rising case fatality rate — from roughly 3% early in 2026 to nearly 8% more recently — which it attributes partly to incomplete childhood vaccination coverage and delayed care-seeking. Diphtheria is a bacterial throat infection that can cause airway obstruction and heart damage; it is preventable with the standard Td or Tdap booster recommended every 10 years for adults. Travellers to West Africa should confirm their immunisation is current before departure.

Wednesday, 5 November: High-Dose Flu Vaccine Linked to 55% Lower Alzheimer's Risk in Large Observational Study

Researchers at UTHealth Houston, reporting in Neurology, found that adults aged 65 and older who received the high-dose annual influenza vaccine had a nearly 55% lower rate of Alzheimer's disease diagnosis over at least 25 months compared with those who received the standard-dose formulation. The analysis drew on insurance claims records for approximately 121,000 high-dose recipients and more than 44,000 standard-dose recipients. This is an observational study: it cannot establish causation, and people who seek out high-dose vaccines may differ from standard-dose recipients in other health-protective behaviours. The team's proposed mechanism — that preventing influenza-related neuroinflammation may slow neurodegeneration — is biologically plausible but unproven. This builds on earlier work from the same group, which linked any flu vaccination to a roughly 40% lower Alzheimer's incidence. A randomised controlled trial would be needed to establish whether the vaccine itself drives the reduction.

Tuesday, 6 November: FDA Grants Fast Track to FRP-003 for Long COVID Fatigue

The US Food and Drug Administration granted Fast Track designation to FRP-003, an investigational oral botanical compound from Front Range Pharmaceuticals, for fatigue in adults with long COVID — a condition for which no treatment has yet received regulatory authorisation. The FDA simultaneously cleared an Investigational New Drug application, paving the way for a Phase 2 randomised, double-blind, placebo-controlled trial of approximately 220 adults. Participants will be randomised 1:1:1 to one of two FRP-003 doses or matching placebo taken twice daily for 56 days; enrolment is expected to begin in 2027 and to run for approximately 12 months. Two earlier, small-scale studies of FRP-003 reported no serious adverse events, though neither was designed to assess efficacy and no peer-reviewed clinical results have been published. Fast Track designation accelerates FDA dialogue and may enable rolling review; it is not a prediction of approval.

The content of this roundup is journalistic reporting and does not constitute medical advice. Readers should consult a qualified clinician or pharmacist before making any change to their treatment, medication, or health management.