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Intraperitoneal mRNA LNPs program CAR macrophages in vivo — preclinical tumor gains
Researchers reported a platform that uses intraperitoneal mRNA lipid nanoparticles to program chimeric antigen receptor (CAR) macrophages directly in the body, boosting antitumor activity in...
Sanofi bulks up 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 portfolio. The...
FDA clears Yartemlea: first TA‑TMA therapy
The U.S. Food and Drug Administration approved Omeros Corp.’s Yartemlea (narsoplimab) as the first indicated therapy for hematopoietic stem cell transplant‑associated thrombotic microangiopathy...
Wegovy goes oral: FDA clears Novo’s semaglutide pill
The FDA approved Novo Nordisk’s once‑daily oral semaglutide (Wegovy pill), the first oral GLP‑1 authorized for weight loss in adults and approved for reducing major cardiovascular events in the...
Medicare to test GLP‑1 coverage — payer barrier shifts
CMS plans a voluntary pilot model that would let Medicare Part D plans and participating state Medicaid programs cover GLP‑1 drugs for weight management, a threshold event for obesity drug access....
Agios wins nod for mitapivat — approval in thalassemia
The FDA approved Agios Pharmaceuticals’ mitapivat under the brand name Aqvesme for thalassemia, following a three‑month review delay and missed PDUFA deadline. The approval provides patients with...
Court knocks out FDA LDT rule — regulatory terrain altered
A federal district court vacated the FDA’s final rule on regulation of laboratory‑developed tests (LDTs), delivering what commentators called the regulatory story of 2025. The court decision...
Vyriad raises tranche to push in‑vivo CAR‑T VV‑169 to clinic
Vyriad closed a $25 million final tranche of its Series B financing, taking the round to $85 million and earmarking proceeds to advance VV‑169, its in‑vivo CAR‑T candidate, into first‑in‑human...
Enveda’s ENV‑6946 enters clinic — oral IBD candidate
Enveda Therapeutics received IND clearance and initiated a phase I trial of ENV‑6946, a first‑in‑class oral small molecule intended to treat inflammatory bowel disease, including Crohn’s disease...
Orum’s ORM‑1153 shows AML edge vs venetoclax in tests
Orum Therapeutics reported preclinical data showing ORM‑1153 outperformed venetoclax in acute myeloid leukemia models, suggesting a potential efficacy advantage for Orum’s degrader‑antibody...
Patient death disclosed in Pfizer’s Hympavzi hemophilia trial
Pfizer disclosed the death of a participant in a long‑term extension trial of Hympavzi (marstacimab), reporting a cerebellar infarction followed by a cerebral hemorrhage. The company communicated...
Sanofi shells out $2.2B for Dynavax: vaccine push accelerates
Sanofi agreed to acquire Dynavax Technologies for about $2.2 billion in cash in a deal announced Dec. 23–24, 2025. The transaction gives Sanofi immediate commercial rights to Dynavax’s hepatitis B...
FDA clears Wegovy pill: oral GLP‑1 enters obesity market
The U.S. Food and Drug Administration approved Novo Nordisk’s oral semaglutide formulation for weight management, clearing the first oral GLP‑1 pill for obesity and marking a new phase in the...
FDA greenlights Omeros’ Yartemlea: first TA‑TMA therapy approved
The U.S. FDA approved Omeros Corp.’s Yartemlea (narsoplimab) as the first treatment for hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA). The decision establishes...
CMS to pilot GLP‑1 coverage: Medicare edges into obesity drugs
CMS announced a voluntary test model to allow Medicare Part D plans and state Medicaid programs to cover GLP‑1 drugs prescribed for weight management. The pilot aims to evaluate mechanisms to...
Asia deal wave: Harbour nets BMS tie‑up; Jacobio inks $1.9B AstraZeneca pact
Two major pharma deals out of Asia closed late in 2025: Harbour Biomed struck a multispecific antibody collaboration with Bristol Myers Squibb that includes roughly $90 million up front and...
Death in Hympavzi trial triggers safety probe — hemophilia program under scrutiny
Pfizer disclosed the death of a participant in a long‑term extension trial of Hympavzi (marstacimab), reporting a cerebellar infarction followed by cerebral hemorrhage. The company notified the...
Vyriad closes $25M tranche — in‑vivo CAR‑T candidate moves to clinic
Vyriad Inc. closed a $25 million final tranche to its Series B round, bringing total Series B proceeds to $85 million. The financing is earmarked to support first‑in‑human testing of VV‑169, an...
Early clinical starts: Enveda’s oral IBD drug and Simcere’s cancer candidate enter trials
Enveda Therapeutics secured FDA IND clearance and initiated a phase I trial of ENV‑6946, a first‑in‑class oral small molecule for inflammatory bowel disease. The move starts human testing for a...
Device approvals: FDA clears Crescom AI bone‑age tool; Edwards wins Sapien M3 nod
The FDA granted 510(k) clearance to Crescom’s MediAI‑BA, an AI‑powered pediatric and adolescent bone age analysis application, citing specialist‑level accuracy in prior trials. The device predicts...