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Engineered vesicles improve oral antibiotics and preserve gut microbiome
Researchers published evidence in Nature Communications that engineered vesicles can enhance oral antibiotic absorption while mitigating gut dysbiosis, offering a potential route to boost efficacy...
Intraperitoneal mRNA programs CAR macrophages – a new tumor‑targeting route
Investigators developed mRNA lipid nanoparticles (LNPs) that program macrophages in the peritoneal cavity to express chimeric antigen receptors (CARs), demonstrating enhanced antitumor activity in...
Court overturns FDA LDT rule: regulatory fallout grows
A federal court struck down the FDA’s final rule to regulate lab‑developed tests (LDTs), delivering a major legal setback to the agency’s 2025 regulatory agenda and punctuating a year dominated by...
FDA clears Crescom’s MediAI‑BA: pediatric bone‑age AI gets 510(k)
Crescom received U.S. FDA 510(k) clearance for MediAI‑BA, an AI‑powered pediatric and adolescent bone‑age analysis software cleared for clinical use. The class II device evaluates hand and wrist...
Sanofi snaps up Dynavax for $2.2B — MS drug hits CRL
Sanofi agreed to acquire Dynavax Technologies for $2.2 billion in cash, buying a commercial hepatitis B vaccine (Heplisav‑B) and a phase I/II shingles candidate, according to company announcements...
Medicare to test GLP‑1 coverage — obesity access threshold crossed
CMS announced a voluntary model to enable Medicare Part D plans and state Medicaid programs to cover GLP‑1 drugs for weight management, marking a threshold event in U.S. obesity care policy. The...
FDA greenlights first TA‑TMA drug: Omeros’ Yartemlea cleared
The U.S. Food and Drug Administration approved Yartemlea (narsoplimab) from Omeros as the first treatment for hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA), the...
Court voids FDA LDT rule — regulatory landscape upended
A federal court struck down the FDA’s final rule to regulate lab‑developed tests (LDTs), marking a major legal reversal for the agency and reshaping diagnostics oversight in 2025. The decision...
Engineered vesicles revive oral antibiotics — gut spared
Researchers published in Nature Communications that engineered vesicles can increase oral antibiotic absorption while protecting the gut microbiome, reporting both improved drug bioavailability...
Intraperitoneal mRNA programs CAR macrophages — new in‑body cell therapy
Researchers demonstrated intraperitoneal delivery of mRNA lipid nanoparticles that program CAR macrophages in situ, enhancing antitumor activity within the peritoneal cavity. The study showed that...
Vyriad closes $25M tranche — in vivo CAR‑T candidate moves to humans
Vyriad closed a $25 million final tranche to its Series B, bringing the round to $85 million, to support first‑in‑human testing of VV‑169, an in vivo CAR‑T candidate for relapsed or refractory...
Enveda starts Phase I of ENV‑6946 — first‑in‑class oral IBD candidate
Enveda Therapeutics received FDA IND clearance and initiated a Phase I trial of ENV‑6946, a first‑in‑class oral small molecule for inflammatory bowel disease, including ulcerative colitis and...
ADC targets mapped across breast cancer metastases — Nature study
A Nature Communications study by Borremans, Pabba, Zels and colleagues profiled expression of antibody‑drug conjugate (ADC) targets across breast cancer metastases and matched normal tissues,...
FDA clears Crescom’s AI bone‑age tool — pediatric device OK'd
Crescom Co. Ltd. received U.S. FDA 510(k) clearance for MediAI‑BA, an AI‑powered pediatric and adolescent bone age analysis software. The device, classified as class II, estimates bone age and...
Sanofi pays $2.2B for Dynavax: HepB vaccine added to lineup
Sanofi agreed to acquire Dynavax Technologies for about $2.2 billion in cash, buying a commercial hepatitis B vaccine and a clinical‑stage shingles candidate. The firms announced the deal as...
Medicare to test GLP‑1 coverage: obesity‑drug access threshold crossed
CMS announced a voluntary model test that would enable Medicare Part D plans and state Medicaid programs to cover GLP‑1 drugs for weight management, marking a threshold shift in public‑payer...
FDA approves Omeros’ Yartemlea: first TA‑TMA therapy
The U.S. Food and Drug Administration approved Omeros Corporation’s Yartemlea (narsoplimab) as the first indicated therapy for hematopoietic stem cell transplant‑associated thrombotic...
Court strikes down FDA’s LDT rule — regulatory year‑end shock
A federal court ruled against the FDA’s final rule to regulate laboratory‑developed tests (LDTs), overturning an agency effort to bring many LDTs under stricter federal oversight. Legal challenges...
HHS proposes rollback: cuts health‑tech certification and AI transparency
HHS published a proposed rule that would roll back multiple Biden‑era policies, pare back health‑tech certification criteria and remove planned transparency requirements for healthcare AI tools....
Crescom wins FDA clearance for MediAI‑BA: pediatric bone‑age AI cleared
Crescom Co. Ltd. received FDA 510(k) clearance for MediAI‑BA, its AI‑powered software that evaluates pediatric and adolescent bone age and predicts adult height from hand and wrist X‑rays. The...