Sensei Biotherapeutics has changed its name to Faeth Therapeutics following its February 2026 acquisition of the biotechnology company. The name change accompanies a $200 million private placement financing to advance PIKTOR, an investigational all-oral multi-node inhibitor targeting the PI3K/AKT/mTOR pathway in endometrial and breast cancer. Topline Phase 2 data in endometrial cancer is anticipated in the second half of 2026.
The U.S. FDA has accepted Gilead's application for an investigational once-weekly oral lenacapavir for HIV prevention, with a review date set for February 2027. Concurrently, PEPFAR and The Global Fund are expanding access to the twice-yearly injectable version to a total of 3 million people by 2028. Gilead will present new data on both lenacapavir and a novel bictegravir/lenacapavir combination at CROI 2026.
HHS and CMS issued a proposed rule to codify the Medicare Drug Price Negotiation Program, largely formalizing existing guidance. The rule includes new provisions, such as clarifications for new drug formulations. The proposal is now open for public comment.
The FDA has approved three new targeted therapies for different stages of advanced prostate cancer: Truqap for PTEN-deficient tumors, rucaparib for BRCA-mutated castration-resistant disease, and Akeega for BRCA2-mutated castration-sensitive cancer.
Grifols has launched FESILTY (fibrinogen, human-chmt) in the U.S., a fibrinogen concentrate FDA-approved in December 2025 for acute bleeding episodes in patients with congenital fibrinogen deficiency. The highly purified product, developed by Biotest, enables rapid fibrinogen restoration and can be reconstituted in approximately three minutes.
A genetic framework using Mendelian randomization identified and prioritized drug targets for major depression from over 525,000 cases. The study found drugs targeting genetically supported proteins are 2.6 times more likely to succeed and prioritized 54 repurposing opportunities using existing medications for other conditions.
The FDA has granted accelerated approval to Denali Therapeutics' Avlayah (tividenofusp alfa-eknm), the first therapy targeting neurological symptoms of Hunter syndrome. The approval was based on a surrogate endpoint measuring heparan sulfate reduction in cerebrospinal fluid, with confirmatory study results required for full approval. The global Hunter syndrome treatment market is projected to reach $2.6 billion by 2033.
The FDA has cleared an IND for Amphista's novel BRD9 degrader AMX-883 for AML, approved Lantheus' new prostate cancer imaging agent Pylarify TruVu, and accepted Biofrontera's sNDA for Ameluz PDT in superficial basal cell carcinoma. These regulatory milestones span hematologic and solid tumor areas, addressing significant unmet medical needs.
Akeso reported overall survival benefit for ivonescimab plus chemotherapy in Phase III lung cancer study. The company enrolled first patient in Phase Ib/II trial of next-generation HER3 ADC AK138D1 for advanced breast cancer. Akeso also received China approval to start Phase II trials for AK139 bispecific antibody.
New research shows posture-driven retinal vascular changes can predict diabetic retinopathy progression, with smartphone-based imaging detecting early microvascular dysfunction. A five-year study found abnormal arteriolar tortuosity during postural shifts increased progression risk over two-fold.
The U.S. FDA has accepted for filing a New Drug Application for tirabrutinib under the accelerated approval pathway for relapsed or refractory primary central nervous system lymphoma, setting a PDUFA action date of December 18, 2026. The submission is supported by Phase 2 PROSPECT study results showing a 67% overall response rate and 44% complete response rate. If approved, tirabrutinib would be the first BTK inhibitor commercially available in the U.S. for this indication.
At the ADA Scientific Sessions, Novo Nordisk's Wegovy pill surpassed 3 million prescriptions within five months, while Structure Therapeutics and AstraZeneca shared mid-stage GLP-1 data targeting a 2029 launch. The US FDA approved TRUQAP as the first targeted treatment for PTEN-deficient metastatic prostate cancer, reducing disease progression risk by 19% in the CAPItello-281 trial. Meanwhile, two major genomic atlas projects—a 4,098-genome infant gut bacteria catalog and Basecamp Research's Trillion Gene Atlas—aim to advance precision probiotics and AI-driven drug discovery, respectively.
Three biotech companies announce significant funding: Korsana Biosciences secures $175 million for neurodegenerative therapies, Kos Biotechnology Partners closes a $123 million life sciences fund, and ParcelBio launches with $13 million to advance mRNA medicines.
Multiple recent studies evaluate different immunotherapy approaches for advanced NSCLC, including long-term benefits for nivolumab plus ipilimumab with chemotherapy in PD-L1-negative tumors, limited advantages from PD-(L)1 rechallenge strategies, and early positive signals from combining TIGIT and PD-1 inhibitors in PD-L1-high patients.
Researchers recommend a new long-read DNA test as the first choice for rare genetic disorders, showing a 3% higher diagnosis rate. Separately, a Chinese AI diagnostic system called DeepRare achieved 57.18% accuracy using only patient symptoms, with accuracy exceeding 70% when genetic data is included.
The C-POST trial shows adjuvant cemiplimab improves disease-free survival in high-risk cutaneous squamous cell carcinoma, with a hazard ratio of 0.32. Meanwhile, an international Phase III study is testing cemiplimab before surgery in advanced cases. Cemiplimab is FDA-approved for advanced skin cancer but not yet for pre-surgical use.
Patients with stage 4 lung, sarcoma, and gastro-oesophageal cancer describe their experiences with targeted therapies, chemotherapy, and immunotherapy, highlighting varying outcomes and financial challenges.
Three recent drug enforcement operations in Virginia and Alabama led to multiple arrests and seizures of cocaine, fentanyl, methamphetamine, firearms, and over $3,000 in cash. The cases involved separate investigations by county sheriff's offices and drug task forces.
Multiple health product recalls have been announced, including a prescription cholesterol medication for dissolution issues and dietary supplements containing undeclared erectile dysfunction drugs Tadalafil and Sildenafil. The FDA and international regulators warn of potential health risks.
Switzerland will vote on June 14 on a proposal to cap its population at 10 million by 2050, which would restrict migration and potentially end EU free-movement agreements. Corporate leaders and business groups warn of severe labor shortages and economic damage. Polls show the vote is closely contested, with the population having grown rapidly in recent decades.
