Latest Biotech News

The U.S. FDA granted accelerated approval to Rocket Pharmaceuticals’ gene therapy Kresladi (marnetegragene autotemcel), marking the first gene therapy option for severe leukocyte adhesion...

Kodiak Sciences’ tarcocimab tedromer—branded Zenkuda—posted positive Phase 3 results in diabetic retinopathy across the Glow2 program, beating a sham procedure and setting up an accelerated,...

Otsuka is acquiring Transcend Therapeutics to add an experimental neuropsychiatric asset aimed at restoring “neuroplasticity,” in a deal valued at roughly $1.2 billion, including a $700 million...

The FDA cleared Novo Nordisk’s once-weekly basal insulin Awiqli (insulin icodec) injection 700 units/mL for type 2 diabetes, giving the U.S. market its first approval for a once-weekly long-acting...

Maryland’s Department of Health awarded more than $520,000 to 18 groups of fire departments to run multi-cancer early detection (MCED) screening using 20/20 BioLabs’ OneTest blood assay. The grant...

The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of four new drugs and a new form of Sanofi’s multiple myeloma therapy Sarclisa. The CHMP recommendation covers...

Merck is set to acquire Terns Pharmaceuticals in an all-cash deal valued at about $6.7 billion, as the company bolsters its oncology pipeline with an asset positioned for chronic myeloid leukemia....

Novartis agreed to acquire Excellergy for up to $2 billion, aiming to strengthen its immunology strategy and build a next-generation anti-IgE franchise that could serve as a successor to Xolair....

Editas Medicine said the USPTO reaffirmed an earlier Patent Trial and Appeal Board (PTAB) decision supporting Broad Institute inventorship priority for foundational CRISPR/Cas9 genome-editing...

A Keio University-led study identified a gut-immune mechanism that can initiate neuroinflammation in multiple sclerosis models. Researchers reported that intestinal epithelial cells (IECs) with...

The FDA granted accelerated approval to Rocket Pharmaceuticals’ Kresladi (marnetegragene autotemcel), positioning it as the first gene therapy option for severe leukocyte adhesion deficiency type...

The FDA approved Novo Nordisk’s once-weekly basal insulin Awiqli (insulin icodec) injection 700 units/mL, clearing a long-awaited shift from daily insulin regimens for type 2 diabetes. Novo’s...

The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of a new subcutaneous formulation of Sanofi’s Sarclisa and four additional new drugs, according to its latest...

AstraZeneca reported “surprise” Phase 3 success for tozorakimab in chronic obstructive pulmonary disease (COPD), winning in two trials—Oberon and Titania—by meeting the main goal of reducing...

Otsuka agreed to acquire Transcend Therapeutics through its U.S. subsidiary in a deal worth about $1.2 billion, including a $700 million upfront payment and up to $525 million in milestones. The...

Novartis agreed to acquire Excellergy in a deal valued at up to $2 billion, aiming to add a next-generation anti-IgE program that could succeed Xolair. Excellergy’s lead asset, Exl-111, is a...

Maryland’s Department of Health awarded more than $520,000 to 18 groups of fire departments to deploy OneTest, a blood-based multi-cancer early detection (MCED) assay from 20/20 BioLabs. The...

UCB selected Gwinnett County, Georgia, for a new U.S. biologics manufacturing facility expected to cost about $2 billion, expanding local production capacity for complex biologics. The planned...

A multi-institutional team led by Northwestern University demonstrated an implantable “living pharmacy” device that can continuously produce multiple biologics inside the body. In a study...

Invivoscribe secured CE-IVDR certification for its IdentiClone Dx IGH assay, designed to detect immunoglobulin heavy chain (IGH) gene rearrangements in patients with suspected lymphoproliferative...