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Sanofi buys Dynavax for $2.2B — vaccine portfolio boost
Sanofi agreed to acquire Dynavax Technologies for $2.2 billion in cash, securing the commercial hepatitis B vaccine Heplisav‑B and a phase I/II shingles candidate. The deal, announced Dec. 24,...
FDA clears Wegovy pill — first oral GLP‑1 for weight loss
The U.S. Food and Drug Administration approved Novo Nordisk’s once‑daily Wegovy (semaglutide) tablet for weight management, marking the first oral GLP‑1 approved for obesity. Clinical trial data...
CMS to pilot GLP‑1 coverage — Medicare edges into obesity drugs
The Centers for Medicare & Medicaid Services announced plans to test a voluntary model enabling Medicare Part D plans and state Medicaid programs to cover GLP‑1 drugs for weight management. CMS...
FDA greenlights Omeros’ Yartemlea — first TA‑TMA therapy
The FDA approved Omeros Corporation’s Yartemlea (narsoplimab) as the first treatment for hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA), a severe complication of...
Agios wins approval for mitapivat — launches Aqvesme in thalassemia
The FDA approved Agios Pharmaceuticals’ mitapivat for the treatment of thalassemia under the brand name Aqvesme, following a three‑month review delay. The approval provides Agios with a newly...
Engineered vesicles boost oral antibiotics — absorption and microbiome gains
Researchers published in Nature Communications that engineered lipid vesicles can enhance gastrointestinal absorption of oral antibiotics while mitigating gut microbiome disruption. The study...
Intraperitoneal mRNA programs CAR macrophages — in vivo immune engineering
Researchers reported a technique using intraperitoneal delivery of mRNA lipid nanoparticles to program CAR macrophages in vivo, enhancing anti‑tumor activity against peritoneal cancers. The...
Enveda’s ENV‑6946 enters clinic — oral small molecule for IBD
Enveda Biosciences received FDA IND clearance and initiated a Phase I trial for ENV‑6946, a first‑in‑class oral small molecule targeting inflammatory bowel disease (IBD), including ulcerative...
FDA clears Crescom’s MediAI‑BA — pediatric bone‑age AI gets 510(k)
Crescom Co. Ltd. secured FDA 510(k) clearance for MediAI‑BA, an AI‑powered pediatric and adolescent bone age analysis tool that assesses growth plate status from hand and wrist X‑rays and suggests...
Singlera inks EU deal with Pure Medical — expands cfDNA cancer reach
Singlera Genomics signed a research and distribution agreement with EU‑based Pure Medical to commercialize its mTitan and mGuard cell‑free DNA methylation assays across several European countries....
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...