Grail’s Galleri Blood Test Falls Short in Large Cancer-Screening Study, Shares Sink 50%

Frank Vinluan / medcitynews - Despite missing statistical significance, Grail said the observation of trending improvement suggests potential for better results with more time, so the company is extending follow up by up to a year. More detailed trial results will be submitted for pre…

AI Summary: Grail’s multi‑cancer Galleri blood screen failed to meet the primary endpoint in a large UK trial, undermining claims of near-term population screening utility and prompting a sharp market reaction. Researchers noted signals that merit further study, but the study outcome raises fresh doubts about broad clinical deployment and reimbursement prospects.

'Universal' nasal-spray vaccine protects against viruses, bacteria and allergens in mice

livescience - In an early animal test, a new nasal-spray vaccine has shown promise against a variety of germs and a common allergen, scientists report.

AI Summary: Scientists reported a nasal-spray vaccine that protected mice against a range of respiratory viruses, bacteria and even a common allergen, a tantalizing step toward a universal respiratory vaccine. The animal data look promising, but human trials are essential before anyone ditches annual shots for a single spritz and a prayer.

Your Cat May Share the Same Cancer Genes as You, and Offer Clues for Treatment

discovermagazine - Learn how cats and humans can share key cancer mutations — and why those similarities could guide future treatment research.

AI Summary: A comparative genomics study finds the household cat shares key cancer mutations with humans across several tumor types, offering a practical animal model for understanding tumor biology and testing therapies. Researchers suggest these feline-human parallels could accelerate translational oncology for both species, turning a once-dismissed pet anecdote into useful science.

Immune cells from pediatricians help uncover an antibody cocktail against RSV and hMPV

medicalxpress - Researchers in China recently published a study in Science Translational Medicine describing a new antibody cocktail for protection against two common viruses. The proposed preventative treatment consists of antibodies identified in pediatricians who have…

AI Summary: Researchers mined the blood of pediatricians — occupationally exposed to many childhood viruses — to isolate highly potent antibodies, then combined them into a cocktail that neutralizes respiratory syncytial virus (RSV) and human metapneumovirus (hMPV). Preclinical results show strong neutralization and protection, offering a promising prophylactic or therapeutic option for infants and at-risk adults.

FDA formalizes one pivotal trial policy via NEJM perspective

Zachary Brennan / endpoints - Top FDA officials said that a single pivotal trial requirement will be the “new default standard” for drug approvals, a move that goes beyond the agency’s prior discretion around not requiring two trials. In a ...

AI Summary: The FDA has moved to make a single pivotal trial the new default for drug approvals, abandoning the long-standing two-study standard to speed access and ease OTC transitions. The policy, outlined by agency leaders and discussed in a NEJM perspective, raises questions about evidence thresholds and downstream safety monitoring. Welcome to faster approvals — now let's hope that lone study behaves.

F.D.A. Reverses Decision and Agrees to Review Moderna’s Flu Vaccine

Christina Jewett and Rebecca Robbins / nytimes - Moderna said it had held further discussions with regulators and announced that the agency would accept the company’s application for approval of its flu vaccine that uses mRNA technology.

AI Summary: After renewed discussions with the company, the FDA reversed its earlier stance and agreed to accept Moderna’s amended application for an mRNA seasonal influenza vaccine. Regulators will now evaluate the submitted safety and efficacy data to determine whether the shot meets approval standards — a regulatory about-face that will keep flu-watchers and investors awake.

Ocular Therapeutix Eyes FDA Filing After Wet AMD Drug Tops Regeneron’s Eylea in Phase 3 Test

Frank Vinluan / medcitynews - In the first of two Phase 3 tests, Ocular Therapeutix’s Axpaxli met the main goal of helping maintain vision in patients with the wet form of age-related macular degeneration. The Ocular drug was compared to Eylea, a blockbuster wet AMD drug marketed by R…

AI Summary: Ocular Therapeutix’s investigational drug Axpaxli met its primary endpoint in a pivotal Phase 3 trial, showing superiority to Regeneron’s Eylea for wet age‑related macular degeneration. The company plans an FDA submission, positioning Axpaxli as a potential new first‑line therapy if regulators agree — a welcome development for patients tired of frequent injections.

Extracorporeal liver cross-circulation using transgenic xenogeneic pig livers with brain-dead human decedents

Abraham Shaked / nature - Nature Medicine, Published online: 09 February 2026; doi:10.1038/s41591-025-04196-3In a study of four brain-dead human decedents, extracorporeal liver cross-circulation using genetically modified pig livers provides essential hepatic functions, supporting…

AI Summary: In a controversial translational study investigators ran blood between genetically modified pig livers and brain‑dead human decedents using an extracorporeal cross‑circulation system to assess organ viability and function. The work explores a potential bridge to expand transplantable organs, laying technical groundwork while prompting ethical and regulatory questions about next steps.

New FDA-Approved Device Uses Electric Fields to Treat Pancreatic Cancer

discovermagazine - Learn more about the newly approved wearable treatment that disrupts pancreatic cancer tumor growth while letting patients continue daily life at home.

AI Summary: The FDA approved a wearable device that delivers alternating electric fields to disrupt pancreatic tumor growth, letting patients remain ambulatory while receiving treatment. Clinicians hail the noninvasive approach as a new adjunct to standard care, aiming to slow progression in a cancer that’s notoriously hard to treat — and yes, it literally plugs into hope.

HPV cancer vaccine slows tumor growth and extends survival in preclinical model

medicalxpress - Throughout the past decade, Northwestern University scientists have uncovered a striking principle of vaccine design: Performance depends not only on vaccine components but also on vaccine structure. After proving this concept across multiple studies, the…

AI Summary: A therapeutic HPV vaccine showed tumor shrinkage and longer survival in preclinical models of HPV‑driven oropharyngeal cancer, suggesting a possible adjunct to surgery and chemo‑radiation. Researchers say the approach could boost anti‑tumor immunity and inform next‑stage trials, though human efficacy and safety await clinical proof.

FDA clears 1st blood test for Alzheimer’s in primary care

Ella Jeffries / beckershospitalreview - The first FDA-cleared blood test to assess Alzheimer’s disease in primary care is now available for patients age 55 and older with symptoms of cognitive decline. The test aims to help clinicians rule out Alzheimer’s by identifying individuals unlikely to …

AI Summary: Regulators cleared the first blood test for Alzheimer’s for primary‑care use while researchers published capillary sampling methods and analyses showing blood biomarkers’ promise for dementia diagnosis. Together these developments push biomarker testing out of specialty clinics and toward routine care — promising earlier detection, though concerns about population diversity, accuracy thresholds and rollout logistics remain.

Studies test whether gene-editing can fix high cholesterol. For now, take your medicine

medicalxpress - Scientists are testing an entirely new way to fight heart disease: a gene-editing treatment that might offer a one-time fix for high cholesterol.

AI Summary: Researchers are testing gene‑editing approaches aimed at providing a single‑procedure solution for elevated LDL cholesterol. Early human studies probe safety and durability, but experts urge patients to continue proven lipid‑lowering therapies for now. The line between ambitious science and everyday clinical care remains prudently guarded.

Eli Lilly Expands Its In Vivo Ambitions, Acquiring Cell Therapy Startup Orna for up to $2.4B

Frank Vinluan / medcitynews - Orna Therapeutics brings Eli Lilly an in vivo cell therapy ready for Phase 1 testing as a potential treatment for autoimmune diseases. Lilly is now the latest pharma company to use M&A to enter this growing field, following deals made in the past year by …

AI Summary: Eli Lilly is acquiring Orna Therapeutics for up to $2.4 billion to secure in‑vivo cell‑therapy capabilities and jump‑start its presence in CAR‑T and immune‑resetting platforms. The deal signals big pharma’s move to couple traditional drug development muscle with next‑generation cell‑engineering, accelerating clinical testing and commercialization plans.

Sanofi's Paul Hudson out, with Belén Garijo to step in as new CEO

Reynald Castañeda / endpoints - Paul Hudson is stepping down from his post as CEO of Sanofi, and his last day will be Feb. 17. The French drugmaker's board decided not to renew Hudson's mandate on ...

AI Summary: Sanofi’s board has opted not to renew Paul Hudson’s tenure, installing Belén Garijo as the new chief executive amid mixed reactions. The leadership swap arrives as the French drugmaker faces pipeline pressures and investor impatience—expect strategic shuffles, belt‑tightening and plenty of corporate soul‑searching with a side of investor scrutiny.

BridgeBio Stands Tall as Phase 3 Data Put Dwarfism Drug on Track for FDA Filing

Frank Vinluan / medcitynews - Infigratinib achieved statistically significant improvement in growth rate and body composition in a Phase 3 clinical trial that tested the BridgeBio Pharma drug in achondroplasia, the most common form of dwarfism. Regulatory submissions are planned for l…

AI Summary: BridgeBio reported statistically significant Phase 3 results for infigratinib in achondroplasia, showing improved growth rates and body composition, moving the program toward an FDA filing. The readout strengthens BridgeBio’s rare-disease momentum and sets the stage for regulatory discussions and potential market entry.

Microfluidic automation improves oocyte recovery from follicular fluid of patients undergoing in vitro fertilization

Baris R. Mutlu / nature - Nature Medicine, Published online: 12 February 2026; doi:10.1038/s41591-026-04207-xThe authors developed a microfluidic device, FIND-Chip, designed to automate and enhance oocyte recovery from follicular fluid, a process traditionally done manually. When …

AI Summary: Researchers developed a microfluidic automation device that finds and recovers viable oocytes missed by standard follicular‑fluid inspection, increasing oocyte yield for IVF. The approach — validated in lab and early clinical settings — promises to improve embryo selection and fertility outcomes by reducing human oversight errors in the lab.

FDA refuses to review Moderna flu vaccine

Ella Jeffries / beckershospitalreview - Moderna has received a refusal-to-file letter from the FDA’s Center for Biologics Evaluation and Research for its biologics license application for mRNA-1010, its investigational seasonal influenza vaccine. The letter, signed by Vinayak Prasad, MD, chief …

AI Summary: Moderna’s mRNA flu vaccine application has been rejected by the FDA—Moderna received a refusal‐to‐file letter while accusing the agency of shifting its review standards. Multiple reports echo this regulatory setback, fueling industry concerns over consistent, transparent decision‐making.

AstraZeneca gets CRL for prefilled pen version of lupus drug Saphnelo

Anna Brown / endpoints - The FDA has handed AstraZeneca a complete response letter for the subcutaneous prefilled, self-injectable pen of Saphnelo for systemic lupus erythematosus (SLE), a month after the asset gained approval in Europe ...

AI Summary: AstraZeneca’s application to market its subcutaneous prefilled pen formulation of Saphnelo for treating lupus has hit a roadblock after the FDA issued a complete response letter. The decision delays the drug’s approval and raises questions about its future in the competitive immunotherapy market.

#ISC26: Bayer’s asundexian reduced ischemic strokes by 26% in Phase 3 trial

Ayisha Sharma / endpoints - Bayer shared more details from its unexpected win in a Phase 3 study testing its next-generation blood thinner for secondary stroke prevention. The factor XIa inhibitor, named asundexian, reduced the occurrence of ischemic stroke by ...

AI Summary: Bayer’s latest Phase 3 study of asundexian has shown a 26% reduction in secondary ischemic stroke risk—without an increased bleeding risk. This compelling data bolsters the drug’s prospects as a blockbuster in stroke prevention and underscores Bayer’s commitment to advancing cardiovascular therapies.