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Engineered vesicles boost oral antibiotic absorption — gut dysbiosis curbed
A Nature Communications study presented engineered vesicles that improve oral antibiotic absorption while reducing gut microbiome disruption. The vesicles enhanced drug delivery across the...
FDA approves Aqvesme (mitapivat) for thalassemia — Agios clears a major milestone
The FDA approved Agios Pharmaceuticals’ mitapivat under the brand name Aqvesme to treat certain forms of thalassemia, marking a key regulatory victory after a delayed review. The small‑molecule...
Sanofi doubles down on 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 vaccine portfolio. The...
FDA clears Omeros’ Yartemlea: first TA‑TMA therapy
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),...
Agios wins approval – mitapivat branded Aqvesme for thalassemia
The FDA approved Agios Pharmaceuticals’ mitapivat for the treatment of thalassemia under the brand name Aqvesme, a decision announced Dec. 24 after a short regulatory delay. The approval marks a...
Medicare pilots GLP‑1 coverage: obesity drugs move closer to seniors
CMS launched a voluntary model to let Medicare Part D plans and state Medicaid programs cover GLP‑1 drugs for weight management, representing a threshold event for obesity drug access in the U.S....
Vyriad closes financing – VV‑169 moves to first‑in‑human
Vyriad closed a $25 million final tranche of its Series B financing, bringing the round to $85 million and funding first‑in‑human testing of VV‑169, the company’s in vivo CAR‑T candidate for...
Enveda’s ENV‑6946 enters clinic: first‑in‑class oral IBD program
Enveda Biosciences secured FDA IND clearance and initiated a Phase I trial for ENV‑6946, an oral small molecule positioned as a first‑in‑class therapy for inflammatory bowel disease, including...
Engineered vesicles improve oral antibiotics and preserve gut microbiome
Researchers published evidence in Nature Communications that engineered vesicles can enhance oral antibiotic absorption while mitigating gut dysbiosis, offering a potential route to boost efficacy...
Intraperitoneal mRNA programs CAR macrophages – a new tumor‑targeting route
Investigators developed mRNA lipid nanoparticles (LNPs) that program macrophages in the peritoneal cavity to express chimeric antigen receptors (CARs), demonstrating enhanced antitumor activity in...
Court overturns FDA LDT rule: regulatory fallout grows
A federal court struck down the FDA’s final rule to regulate lab‑developed tests (LDTs), delivering a major legal setback to the agency’s 2025 regulatory agenda and punctuating a year dominated by...
FDA clears Crescom’s MediAI‑BA: pediatric bone‑age AI gets 510(k)
Crescom received U.S. FDA 510(k) clearance for MediAI‑BA, an AI‑powered pediatric and adolescent bone‑age analysis software cleared for clinical use. The class II device evaluates hand and wrist...
Sanofi snaps up Dynavax for $2.2B — MS drug hits CRL
Sanofi agreed to acquire Dynavax Technologies for $2.2 billion in cash, buying a commercial hepatitis B vaccine (Heplisav‑B) and a phase I/II shingles candidate, according to company announcements...
Medicare to test GLP‑1 coverage — obesity access threshold crossed
CMS announced a voluntary model to enable Medicare Part D plans and state Medicaid programs to cover GLP‑1 drugs for weight management, marking a threshold event in U.S. obesity care policy. The...
FDA greenlights first TA‑TMA drug: Omeros’ Yartemlea cleared
The U.S. Food and Drug Administration approved Yartemlea (narsoplimab) from Omeros as the first treatment for hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA), the...
Court voids FDA LDT rule — regulatory landscape upended
A federal court struck down the FDA’s final rule to regulate lab‑developed tests (LDTs), marking a major legal reversal for the agency and reshaping diagnostics oversight in 2025. The decision...
Engineered vesicles revive oral antibiotics — gut spared
Researchers published in Nature Communications that engineered vesicles can increase oral antibiotic absorption while protecting the gut microbiome, reporting both improved drug bioavailability...
Intraperitoneal mRNA programs CAR macrophages — new in‑body cell therapy
Researchers demonstrated intraperitoneal delivery of mRNA lipid nanoparticles that program CAR macrophages in situ, enhancing antitumor activity within the peritoneal cavity. The study showed that...
Vyriad closes $25M tranche — in vivo CAR‑T candidate moves to humans
Vyriad closed a $25 million final tranche to its Series B, bringing the round to $85 million, to support first‑in‑human testing of VV‑169, an in vivo CAR‑T candidate for relapsed or refractory...
Enveda starts Phase I of ENV‑6946 — first‑in‑class oral IBD candidate
Enveda Therapeutics received FDA IND clearance and initiated a Phase I trial of ENV‑6946, a first‑in‑class oral small molecule for inflammatory bowel disease, including ulcerative colitis and...