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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...
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...