Latest Biotech News

Replimune won an FDA accelerated approval for its oncolytic viral therapy Tudriqev in advanced melanoma, following a rejection-to-resubmission path and a positive advisory committee vote in under...

The FDA will convene an advisory committee meeting in September to review Grail’s controversial multi-cancer test after it failed to meet the primary endpoint in a large randomized UK trial. The...

Illumina launched the locally manufactured MiSeq i100 Series-CN sequencer in China, positioning the move as a step forward for its “in China, for China” strategy. The instrument is described as...

Latigo Biotherapeutics priced an upsized IPO, raising $345.6 million to advance a non-opioid pain pipeline targeting the Nav1.8 pathway. The offering reflects continued strength in larger biotech...

The FDA accelerated fast-track and priority-review pathways for multiple oncology programs in July, expanding regulatory attention across colorectal, anal, prostate, head and neck, and lymphoma...

Natera said it is preparing for faster prospective study readouts designed to clarify the clinical utility of its Signatera MRD test across tumor types. The company’s interventional “SIGNAL”...

10x Genomics raised its 2026 revenue outlook as booked orders for its Atera spatial biology platform exceeded prior annual unit plans. The company said Atera shipping begins in the second half of...

Terremoto named Mirati vet Christensen as CEO, as the start-up looks to execute on its next phase as a well-funded company. The leadership move follows the kind of commercial and operational ramp...

Shape Therapeutics partnered with the Rett Syndrome Research Trust to advance SHP-401, an investigational one-time gene therapy for Rett syndrome. The collaboration is designed to support...

FDA awarded IPS Heart’s ISX9-CPC rare pediatric drug designation for cardiomyopathies associated with dystrophinopathies. The designation can provide development incentives intended to support...

Replimune’s oncolytic viral therapy Tudriqev has won FDA accelerated approval for advanced melanoma, completing a fast-moving regulatory turnaround after the program was rejected previously and...

The FDA granted fast track designation in July for multiple oncology programs spanning colorectal cancer, anal cancer, and malignant pleural mesothelioma, alongside priority review actions for...

Otsuka’s Voyxact (anti-APRIL) is raising expectations for an IgA nephropathy treatment reset after phase 3 eGFR slope data suggested it may halt or reverse kidney function decline. The program’s...

Latigo Biotherapeutics priced an IPO that raised about $345.6 million to advance a non-opioid pain pipeline focused on the Nav1.8 ion-channel pathway. The company increased share count and priced...

Blossomhill Therapeutics priced a $150 million IPO to fund its macrocyclic cancer drug pipeline, including next-generation inhibitors aimed at oncology targets such as EGFR-mutant non-small-cell...

10x Genomics lifted its 2026 revenue outlook as customer interest in its Atera spatial biology platform accelerated ahead of shipments in the second half of the year. Management attributed the...

Dana-Farber Cancer Institute researchers unveiled a platform to systematically discover molecular glue degraders, targeting a broader set of E3 ligases for cancer therapy development. The Nature...

Natera said it is preparing to accelerate prospective study readouts for its Signatera MRD test, with a view toward demonstrating clinical utility across tumor types. The company highlighted...

The FDA will hold an advisory committee meeting in September to review Grail’s controversial cancer test after it failed to meet the primary endpoint in a large, randomized UK trial. The upcoming...

Oak Ridge National Laboratory introduced a platform designed to pinpoint genetic triggers that switch microbes into efficient factories for chemicals and materials, enabling faster bacterial...