Latest Biotech News

The FDA granted accelerated approval to Denali Therapeutics’ Hunter syndrome treatment Avlayah (tividenofusp alfa), marking a notable shift in the rare-disease review environment after multiple...

The FDA approved Corcept Therapeutics’ Lifyorli (relacorilant) for ovarian cancer months ahead of schedule in combination with nab-paclitaxel. The approval covers adults with platinum-resistant...

Merck agreed to acquire Terns Pharmaceuticals in an all-cash deal valued at about $6.7 billion, bringing the CML candidate TERN-701 into Merck’s oncology portfolio. The transaction is expected to...

Kodiak Sciences reported positive phase III Glow2 (tarcocimab tedromer), setting up an accelerated multi-indication BLA path for the newly branded Zenkuda in diabetic retinopathy. The topline...

Pinnacle Medicines raised $89 million in a series B to advance its oral peptide programs, including next steps across its chemistry and clinical pipeline. The round brings Pinnacle’s total capital...

UCB selected Gwinnett County, Georgia for a new 460,000-square-foot biologics manufacturing facility expected to cost around $2 billion. The site is designed to use a digital-first approach...

The FDA approved Rocket Pharma’s gene therapy Kresladi for severe leukocyte adhesion deficiency type 1 (LAD-1), a highly ultra-rare disorder that exposes children to life-threatening infections....

Idel Therapeutics closed a €9 million seed round (about $10.4 million) to develop an intracellular delivery technology aimed at getting cytotoxic drugs into the cytosol of tumor cells. The company...

Invivoscribe obtained CE-IVDR certification for its IdentiClone Dx IGH assay, a test intended to detect immunoglobulin heavy chain (IGH) gene rearrangements in patients with suspected B-cell...

Wave Life Sciences’ obesity program hit investor disappointment after the company reported a roughly 1% body-weight reduction over six months in its Inlight phase I follow-up. Shares fell sharply...

The FDA cleared Denali Therapeutics’ Hunter syndrome drug Avlayah (tividenofusp alfa) under an accelerated approval pathway, reversing recent scrutiny and rejection patterns for rare disease...

Merck agreed to acquire Terns Pharmaceuticals in an all-cash $6.7 billion deal, valuing Terns at about $53 per share. The transaction centers on TERN-701, an oral allosteric BCR::ABL tyrosine...

Kodiak Sciences reported positive Phase 3 top-line results from Glow2 for tarcocimab tedromer in diabetic retinopathy, shifting investor expectations after prior setbacks. The company said the...

Wave Life Sciences disclosed Phase 1 data from its first-in-human Inlight trial of WVE-007, an INHBE GalNAc-siRNA candidate for obesity, and the market reacted sharply. Investors pulled back after...

Maze Therapeutics disclosed topline Phase 2 results for MZE829, an oral APOL1 inhibitor targeting APOL1-mediated kidney disease and related patient subgroups. The company reported a clinically...

Novo Nordisk and United Biotechnology reported additional Phase 2 results for a China-developed next-generation triple incretin therapy, UBT-251. The companies said the regimen outperformed...

Pinnacle Medicines secured an $89 million Series B co-led by LAV and Foresite Capital to advance its oral peptide programs. The funding brings Pinnacle’s total capital raised to $134 million and...

Biotech deal activity in South Korea highlighted renewed momentum across platforms and oncology assets. Alteogen signed a potential $579 million license deal with Biogen, while Celltrion boosted...

Novartis faces a class-action lawsuit alleging it used tracking tools on consumer-facing branded drug websites to share sensitive patient information without consent. The complaint was filed in...

Cold Spring Harbor Laboratory researchers reported a mechanistic link between cancer immune responses and autoimmune brain disease in Nature. Their findings focus on ectopic NMDAR expression in...