Recent News

• Moderna flu vaccine wins unanimous support from FDA panel
  BioPharma Dive – June 18, 2026
  Advisers to the Food and Drug Administration have thrown their support behind an experimental flu shot from Moderna, heightening the chance that the vaccine could soon complete a dramatic regulatory turnaround. By a unanimous, 9-0 vote, panelists concluded that the benefits of vaccination with Moderna’s mRNA-1010 outweigh the risks in adults between 50 and 64 years of age. Panelists separately all voted that the shot appeared similarly beneficial for adults aged 65 and older.

• S. FDA Accepts Gilead’s Application for Investigational Once-Weekly Oral Yeztugo, Potentially the First Long-Acting Pill for HIV Prevention
  Business Wire – June 15, 2026
  Gilead Sciences, Inc. announced the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application for Yeztugo® (lenacapavir) 300-mg tablet as a potential once-weekly oral formulation for the prevention of HIV as pre-exposure prophylaxis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of February 2, 2027. “This filing reflects Gilead’s continued commitment to advancing new HIV prevention options,” said Dietmar Berger, Chief Medical Officer, Gilead Sciences.
• Organon wins US approval to widen use of arthritis biosimilar drug
  Reuters – June 10, 2026
  Organon said the U.S. Food and Drug Administration has approved the expanded use of its arthritis drug, ​a biosimilar to Roche’s, opens new tab Actemra, to treat ‌a life‑threatening immune reaction in some cancer patients and COVID-19 in patients needing breathing support. The ​FDA approval expands use of its biosimilar, ​Tofidence, to treat severe or life‑threatening cytokine release syndrome in some ⁠cancer patients and for COVID‑19 patients who are receiving oxygen or ​breathing support and systemic corticosteroids.
• Why stem cell-like T cells are shaping the next generation of CAR-T therapies
  Drug Discovery News – June 9, 2026
  CAR-T cell therapy has transformed outcomes in certain blood cancers, but it has always carried the fundamental vulnerability that the cells that make it work do not always last. Infused T cells can expand, contract, and exhaust, in turn leaving patients who initially responded without the sustained immune pressure needed to prevent relapse. Understanding why some patients maintain durable remissions while others do not has pointed the field toward a rare immune cell subset that may hold the answer.
• Cancer vaccines based on mRNA advance, despite US cut
  Reuters – June 9, 2026
  Treatments based on the same mRNA technology that delivered COVID-10 vaccines to market in record time are showing lasting benefit against the deadly skin cancer melanoma and early promise in pancreatic and brain cancers once considered impervious to immune system assault. The apparent breakthroughs in cancer vaccines – deemed one of the fastest-growing segments of cancer research – are arriving even as U.S. officials send conflicting signals about the technology’s merits and safety.
• US FDA approves Pfizer’s bleeding disorder drug for children
  Reuters – June 8, 2026
  The U.S. Food and Drug Administration has approved ‌Pfizer’s, opens new tab drug to prevent or reduce the frequency of bleeding episodes in children and in certain patients with hemophilia, the company said. The nod makes Pfizer’s Hympavzi the first non-factor ​therapy available for pediatric patients with hemophilia B aged 6 to ⁠11 years with or without inhibitors. The regulator also expanded ​the use to include those with hemophilia A or B ​aged 12 years and older with inhibitors, a type of antibody.
• Maternal RSV Vaccination Reduces Infant Hospitalization Risk by 68
  Medscape – June 8, 2026
  Maternal respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccination during pregnancy is associated with more than 65% protection against RSV-associated acute respiratory illness (ARI) hospitalization in infants 90 days or younger. Among 274 hospitalized infants, 11 of 83 with RSV and 71 of 191 control individuals were born to vaccinated individuals, with vaccine effectiveness estimated at 67.6% against ARI hospitalization and 69.0% against lower respiratory tract disease (LRTD) hospitalization.
• Early Research Suggests a Path to Predict and Prevent Lung Cancer
  The New York Times – June 4, 2026
  Scientists have made a discovery that may help prevent some people from developing lung cancer, which kills more people worldwide than any other cancer. A team of more than 80 researchers working across four continents have identified a set of proteins in the blood that accurately predict lung cancers more than five years before diagnosis. The scientists also found early evidence that an existing anti-inflammatory drug could significantly reduce lung cancer risk in people with elevated concentrations of these proteins, which they linked to inflammation.
• Gilead’s Livdelzi scores in rare liver disease trial, portending use in broader patient population
  Fierce Pharma – June 2, 2026
  A phase 3 study of Gilead’s Livdelzi has met its primary endpoint, showing the drug’s ability to normalize a key marker of disease progression for those with the rare liver disorder primary biliary cholangitis (PBC). In the IDEAL trial, which compared Livdelzi to placebo, Gilead’s pill allowed significantly more patients to gain control of their alkaline phosphatase (ALP) levels, which are a key signal of disease progression. The trial’s primary endpoint hinged on the number of patients who achieved ALP levels in the normal range with at least a 15% decrease from baseline, the company said.
• A personalized vaccine for melanoma cut the risk of cancer returning after five years
  NBC News – June 1, 2026
  An experimental vaccine from Moderna and Merck shows promise in keeping deadly skin cancer from returning for years, according to new clinical trial results. The research, presented at the American Society of Clinical Oncology’s annual meeting, found that a personalized mRNA vaccine halved the risk of melanoma returning after five years. The results were also published in the Journal of Clinical Oncology. Melanoma is the deadliest form of skin cancer, and in about half of patients, the disease will come back within the first five years of treatment.
• Pfizer Phase 3 Trials Shows BRAFTOVI Regimen Boosts Progression-Free Survival in Metastatic Colorectal Cance
  American Pharmaceutical Review – June 1, 2026
  Pfizer reported detailed progression-free and overall survival results from Cohort 3 of the Phase 3 BREAKWATER trial evaluating BRAFTOVI (encorafenib) in combination with cetuximab (ERBITUX) and FOLFIRI versus FOLFIRI with or without bevacizumab in previously untreated metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. The randomized cohort, to be presented in a late-breaking oral session at the 2026 American Society of Clinical Oncology Annual Meeting and published in Annals of Oncology, previously met its primary endpoint of objective response rate by blinded independent central review.