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Sanofi pays $2.2B for Dynavax — boosts hepatitis B and shingles lineup
Sanofi agreed to acquire Dynavax Technologies for $2.2 billion in cash, closing a deal that brings Heplisav‑B into Sanofi’s commercial vaccine portfolio and adds a clinical-stage shingles...
FDA clears Wegovy pill: first oral GLP‑1 weight‑loss therapy
The U.S. Food and Drug Administration approved Novo Nordisk’s oral formulation of semaglutide (Wegovy) for weight management, marking the first oral GLP‑1 authorized for obesity. The clearance...
FDA approves Omeros’ Yartemlea — first drug for stem‑cell–associated TA‑TMA
The FDA approved Omeros Corporation’s Yartemlea (narsoplimab), creating the first approved therapy for hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA). The...
CMS to test Medicare coverage for GLP‑1 weight drugs — threshold crossed
The Centers for Medicare & Medicaid Services announced a voluntary model to allow Medicare Part D plans and state Medicaid programs to cover GLP‑1 drugs for weight management under a pilot...
Agios wins FDA approval for Aqvesme — mitapivat cleared in thalassemia
The FDA approved Agios Pharmaceuticals’ mitapivat under the brand name Aqvesme for use in thalassemia, marking a regulatory win after a three‑month delay and missed deadline. Mitapivat’s approval...
Vyriad raises $25M final tranche — funds VV‑169 first‑in‑human push
Vyriad closed a $25 million final tranche of its series B financing, bringing total Series B proceeds to $85 million to fund first‑in‑human testing of VV‑169, an in vivo CAR T candidate targeting...
Enveda’s ENV‑6946 clears IND: oral IBD candidate enters phase I
Enveda Therapeutics obtained FDA investigational new drug clearance and initiated a phase I trial of ENV‑6946, a first‑in‑class oral small molecule for inflammatory bowel disease, including...
Intraperitoneal mRNA LNPs program CAR macrophages — enhance peritoneal cancer therapy
Researchers developed mRNA lipid nanoparticles that program chimeric antigen receptor (CAR) macrophages in vivo via intraperitoneal delivery, enabling localized generation of engineered...
FDA clears Crescom’s MediAI‑BA — AI pediatric bone‑age analysis cleared
Crescom gained U.S. FDA 510(k) clearance for MediAI‑BA, an AI‑powered pediatric and adolescent bone age analysis software that estimates adult height from hand and wrist X‑rays. The clearance...
Singlera inks EU distribution and research pact with Pure Medical — methylation cfDNA assays to Europe
Singlera Genomics signed a research and distribution agreement with EU‑based Pure Medical to commercialize its cell‑free DNA mTitan and mGuard methylation‑based cancer detection assays across...
Court decision upends FDA lab‑developed test rule — regulatory shakeup of 2025
A U.S. district court struck down the FDA’s final rule to regulate lab‑developed tests (LDTs), a ruling that marked the dominant regulatory story of 2025. Legal challenges argued the rule exceeded...
Sanofi buys Dynavax for $2.2B — MS drug CRL also lands
Sanofi agreed to acquire Dynavax Technologies for $2.2 billion in cash, buying a marketed hepatitis B vaccine and a phase I/II shingles candidate, the companies said Dec. 24. The deal, at a...
FDA approves first therapy for TA‑TMA — Omeros’ Yartemlea cleared
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),...
Wegovy pill cleared — oral GLP‑1 launches weight‑loss pill era
The FDA cleared Novo Nordisk’s oral semaglutide formulation for weight loss, granting the company the first approved oral GLP‑1 drug for obesity in the U.S. The approval follows pivotal trials...
CMS to test coverage for GLP‑1s — Medicare, Medicaid pilot set
Centers for Medicare & Medicaid Services will run a voluntary model to let Medicare Part D plans and state Medicaid programs cover GLP‑1 drugs for weight management, a step toward wider public...
Courts rebuke FDA LDT rule — regulatory fight tops 2025
A federal court struck down the FDA’s final rule to regulate lab‑developed tests (LDTs) in 2025, marking the year’s most consequential regulatory decision and halting the agency’s attempt to...
Shionogi pays $2.5B for ALS drug rights — Tanabe deal closes
Shionogi agreed to acquire global rights to edaravone from Tanabe Pharma for $2.5 billion, securing revenue‑generating amyotrophic lateral sclerosis (ALS) therapies marketed in the U.S. as...
Patient death in Pfizer hemophilia trial prompts scrutiny
Pfizer disclosed a fatality in a long‑term extension trial of its tissue factor pathway inhibitor antagonist Hympavzi, reporting a cerebellar infarction followed by cerebral hemorrhage in a...
Early‑stage clinic moves: Enveda IND greenlight and Vyriad financing
Enveda Therapeutics secured FDA IND clearance and launched a phase I trial of ENV‑6946, a first‑in‑class oral small molecule for inflammatory bowel disease including ulcerative colitis and Crohn’s...
Singlera inks EU distribution deal — cfDNA cancer assays head west
Singlera Genomics signed a research and distribution agreement with EU‑based Pure Medical to commercialize its cell‑free DNA (cfDNA) methylation‑based assays in multiple European countries. The...