Latest Biotech News

The FDA has granted accelerated approval to Replimune’s engineered oncolytic virus therapy Tudriqev (RP1) for patients with advanced melanoma that has progressed after prior PD-1–blocking...

Intellia Therapeutics reported it identified a genetic risk factor linked to liver enzyme elevations observed in patients receiving its CRISPR gene-editing treatment for ATTR amyloidosis. The...

Tarsus Pharmaceuticals agreed to acquire Alkeus Pharmaceuticals in a transaction valued at up to $800 million, taking control of Alkeus’ once-daily oral Stargardt therapy ALK-001 (gildeuretinol)....

Expedition Therapeutics raised $115 million in a Series B financing led by General Atlantic, positioning the company to expand clinical development of EXPD-101 in chronic obstructive pulmonary...

Natera submitted its Signatera MRD test to Japan’s PMDA for companion diagnostic approval in muscle-invasive bladder cancer. The filing is supported by data from IMvigor011, which tested...

The FDA approved Moderna’s mRNA influenza vaccine, mFlusiva (mRNA-1010), marking the first licensed seasonal flu vaccine that uses mRNA technology. Moderna’s approval follows an unusual earlier...

Boston Children’s Hospital reported early clinical evidence that oral, encapsulated fecal microbiome transplantation may raise peanut tolerance in a Phase 1 open-label study. Published in Science...

Co-Diagnostics submitted a 510(k) premarket notification for a point-of-care upper respiratory multiplex test that detects and differentiates influenza A/B, COVID-19, and RSV using nasal swab...

Braveheart Bio priced an upsized $382.5 million IPO to fund Phase 3 development of BHB-1893, an oral cardiac myosin inhibitor for obstructive and non-obstructive hypertrophic cardiomyopathy. The...

Mironid raised $46 million in a Series B as its lead program, MR-L45, moved into clinical development for autosomal dominant polycystic kidney disease. The company said MR-L45 is an orally...

The FDA granted accelerated approval to Replimune’s RP1, marketed as Tudriqev, for advanced melanoma after a two-rejection saga that drew public dispute and an FDA advisory vote. The treatment is...

The FDA approved Takeda’s Orzeyful (oveporexton), an oral orexin receptor 2 agonist, as the first therapy designed to address the underlying biology of narcolepsy type 1 in adults. The approval...

The FDA approved Moderna’s mRNA influenza vaccine, mFlusiva (mRNA-1010), marking the first licensed U.S. seasonal flu shot built on mRNA technology. Clearance covers adults aged 50 to 64 and...

Braveheart Bio priced an upsized $382.5 million IPO to advance its oral cardiac myosin inhibitor BHB-1893 into Phase 3 development for obstructive and non-obstructive hypertrophic cardiomyopathy....

Expedition Therapeutics raised $115 million in a Series B financing led by General Atlantic to advance its COPD program, EXPD-101, through ongoing Phase 2 evaluation. The company said the funding...

Forge Biologics outlined how gene-therapy process development is shifting from “can we make it” to “can we make it consistently,” emphasizing seamless integration across early- and late-stage...

Natera submitted its Signatera molecular residual disease test to Japan’s PMDA for companion diagnostic approval in muscle-invasive bladder cancer. The application is supported by data from the...

Tarsus Pharmaceuticals agreed to acquire Alkeus Pharmaceuticals in a transaction valued up to $800 million, bringing a late-stage Stargardt disease program closer to potential commercialization....

Recursion and Genentech announced plans to co-develop a neuroscience small-molecule early discovery program built around the first validated target discovered through an AI-based map created by...

A randomized clinical trial in metastatic breast cancer found that alert-based patient-reported outcome (PRO) monitoring was associated with clinically meaningful reductions in fatigue and...