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Agios’ mitapivat approved as Aqvesme — thalassemia label wins FDA
The FDA approved Agios Pharmaceuticals’ mitapivat for thalassemia under the brand name Aqvesme, marking a regulatory win after a three‑month review delay. The approval provides a new oral option...
Sanofi buys Dynavax for $2.2B — vaccine boost, pipeline reality check
Sanofi agreed to acquire Dynavax Technologies in a roughly $2.2 billion cash deal, adding Dynavax’s commercial hepatitis B vaccine Heplisav‑B and a clinical‑stage shingles candidate to Sanofi’s...
Wegovy pill clears FDA; Medicare edges toward GLP‑1 coverage
The FDA approved Novo Nordisk’s oral semaglutide formulation of Wegovy, marking the first FDA‑cleared oral GLP‑1 indicated for weight loss in adults. Clinical trial data showed substantial mean...
FDA approves Omeros’ Yartemlea — first TA‑TMA therapy
The U.S. Food and Drug Administration approved Omeros Corporation’s Yartemlea (narsoplimab) as the first therapy for hematopoietic stem cell transplant‑associated thrombotic microangiopathy...
Court upends FDA LDT rule; HHS proposes rollbacks for health‑tech rules
A federal court struck down the FDA’s final rule to regulate lab‑developed tests (LDTs), marking a major judicial rebuke of agency rulemaking and reshaping the diagnostics regulatory landscape for...
Pfizer discloses death in Hympavzi hemophilia trial — community questions safety
Pfizer reported the death of a participant in a long‑term extension trial of Hympavzi (marstacimab), a tissue factor pathway inhibitor antagonist for hemophilia, following a cerebellar infarction...
Vyriad closes $25M tranche to advance in vivo CAR‑T into clinic
Vyriad closed a $25 million final tranche of a Series B financing, bringing the round to $85 million to fund first‑in‑human testing of VV‑169, an in vivo CAR‑T candidate for relapsed or refractory...
Enveda’s ENV‑6946 gets IND clearance — oral small molecule enters IBD clinic
Enveda Therapeutics obtained FDA IND clearance and launched a Phase I trial for ENV‑6946, a first‑in‑class oral small molecule for inflammatory bowel disease, including ulcerative colitis and...
Singlera inks EU research and distribution pact with Pure Medical for cfDNA assays
Singlera Genomics signed a research and distribution agreement with EU‑based Pure Medical to commercialize its methylation‑based cell‑free DNA assays (mTitan and mGuard) across selected European...
Crescom wins FDA 510(k) for MediAI‑BA — pediatric bone‑age AI cleared
Crescom Co. Ltd. received FDA 510(k) clearance for MediAI‑BA, an AI‑powered pediatric and adolescent bone‑age analysis software that estimates bone age and predicts adult height from hand‑wrist...
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...