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Sanofi pays $2.2B for Dynavax — MS CRL clouds pipeline
Sanofi agreed to buy Dynavax Technologies for $2.2 billion in cash, acquiring the commercial hepatitis B vaccine Heplisav‑B and a phase I/II shingles candidate. The acquisition closes a gap in...
CMS to pilot GLP‑1 coverage: Medicare edges into obesity drugs
CMS announced a voluntary model test that would enable Medicare Part D plans and some state Medicaid programs to cover GLP‑1 drugs prescribed for weight management. The model is being framed as a...
FDA clears Yartemlea — first therapy for stem‑cell transplant TA‑TMA
The U.S. FDA approved Omeros Corporation’s Yartemlea (narsoplimab) as the first treatment for hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA), a life‑threatening...
Court tosses FDA LDT rule — 2025 regulatory climax
A federal court struck down the FDA’s final rule to regulate laboratory‑developed tests (LDTs), marking a major judicial check on agency rulemaking in 2025. The decision halted a broad effort by...
HHS proposes rule overhaul: trims AI, transparency requirements
The Department of Health and Human Services proposed regulatory changes that would roll back several Biden‑era policies, reduce health tech certification criteria and eliminate planned...
Vyriad closes $25M tranche — funds in vivo CAR‑T (VV‑169) clinic push
Vyriad closed a $25 million final tranche in its Series B, taking 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 clears IND for ENV‑6946 — oral small molecule enters IBD clinic
Enveda Biosciences obtained 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...
Intraperitoneal mRNA LNPs program CAR macrophages — tumor activity rises
Researchers reported preclinical results showing that intraperitoneal delivery of mRNA lipid nanoparticles (LNPs) can program chimeric antigen receptor (CAR) macrophages in vivo, enhancing...
Engineered vesicles boost oral antibiotic absorption — gut dysbiosis curbed
A Nature Communications study presented engineered vesicles that improve oral antibiotic absorption while reducing gut microbiome disruption. The vesicles enhanced drug delivery across the...
FDA approves Aqvesme (mitapivat) for thalassemia — Agios clears a major milestone
The FDA approved Agios Pharmaceuticals’ mitapivat under the brand name Aqvesme to treat certain forms of thalassemia, marking a key regulatory victory after a delayed review. The small‑molecule...
Sanofi doubles down on vaccines: $2.2B Dynavax buy
Sanofi agreed to acquire Dynavax Technologies for $2.2 billion in cash, adding the commercial hepatitis B vaccine Heplisav‑B and a clinical‑stage shingles candidate to its vaccine portfolio. The...
FDA clears Omeros’ Yartemlea: first TA‑TMA therapy
The U.S. Food and Drug Administration approved Omeros Corp.’s Yartemlea (narsoplimab) as the first treatment for hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA),...
Agios wins approval – mitapivat branded Aqvesme for thalassemia
The FDA approved Agios Pharmaceuticals’ mitapivat for the treatment of thalassemia under the brand name Aqvesme, a decision announced Dec. 24 after a short regulatory delay. The approval marks a...
Medicare pilots GLP‑1 coverage: obesity drugs move closer to seniors
CMS launched a voluntary model to let Medicare Part D plans and state Medicaid programs cover GLP‑1 drugs for weight management, representing a threshold event for obesity drug access in the U.S....
Vyriad closes financing – VV‑169 moves to first‑in‑human
Vyriad closed a $25 million final tranche of its Series B financing, bringing the round to $85 million and funding first‑in‑human testing of VV‑169, the company’s in vivo CAR‑T candidate for...
Enveda’s ENV‑6946 enters clinic: first‑in‑class oral IBD program
Enveda Biosciences secured FDA IND clearance and initiated a Phase I trial for ENV‑6946, an oral small molecule positioned as a first‑in‑class therapy for inflammatory bowel disease, including...
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...