Latest Biotech News

The FDA has approved Takeda’s orexin-2 agonist for narcolepsy type 1, giving the sleep-disorder market its first new mechanism in years. The twice-daily pill will be marketed as Orzeyful. Takeda...

The FDA has approved Moderna’s mRNA seasonal flu vaccine, mFlusiva, marking the first U.S.-licensed flu shot built on mRNA technology. The clearance covers adults aged 50–65 and adults 65 and...

CMS’s Cell and Gene Therapy (CGT) Access Model for sickle cell disease is showing promise for Medicaid coverage, but experts say key coverage and data gaps could limit its real-world impact. A...

Natera has submitted Signatera MRD to Japan’s PMDA for companion diagnostic approval in muscle-invasive bladder cancer. The filing supports use of the ctDNA test to guide post-cystectomy treatment...

Intellia has identified a genetic risk factor associated with elevated liver enzymes in patients receiving its CRISPR gene-editing therapy for ATTR amyloidosis. The company said the finding came...

BriaCell received FDA IND clearance for Bria-PROS+, launching the next step for its personalized off-the-shelf, cell-based immunotherapy platform in prostate cancer. The company plans to initiate...

Braveheart Bio priced an upsized $382.5 million IPO to fund Phase III development of BHB-1893, an oral cardiac myosin inhibitor targeting hypertrophic cardiomyopathy. Shares are set to begin...

BillionToOne says it will expand its Unity Fetal Risk Screen NIPT and add a tissue-of-origin feature to its Northstar Select liquid biopsy assay, as Q2 revenue rises. The company is preparing to...

Caris Life Sciences reported a sharp acceleration in revenue growth, driven by rising molecular profiling services and expanded reimbursement coverage for its assays. The company posted...

LifeMine Therapeutics raised $263 million across venture rounds to advance a potentially safer, more convenient immunosuppressant for transplant patients. The financing follows the company’s...

The U.S. FDA has approved Moderna’s mRNA flu vaccine, mFlusiva (mRNA-1010), marking the first licensed seasonal influenza shot built on an mRNA platform. Coverage starts for adults aged 50 to 64...

Sarepta Therapeutics moved to reshape expectations for its Elevidys clinical timeline, disputing the pace laid out for its non-ambulatory study readout. The company said it is delaying the release...

LifeMine Therapeutics raised $263 million across two venture rounds to support what it says could be a safer, more convenient immunosuppressant for transplant patients. Led by serial biotech...

Natera submitted its Signatera MRD test to Japan’s PMDA seeking CDx approval in muscle-invasive bladder cancer. The filing is supported by data from IMvigor011, a double-blind Phase 3 study in...

Brightpath Biotherapeutics received FDA IND clearance for BP-2202, enabling first-in-human dosing in relapsed or refractory multiple myeloma. The company’s plan calls for Phase 1 initiation later...

Pacific Biosciences cut its 2026 revenue guidance after missing Q2 expectations and appointed a replacement CEO, underscoring pressure on performance and execution in long-read sequencing. The...

The $1.8 billion all-stock merger between Supernus and Indivior brings two CNS portfolios together across neurological and addiction indications, with a stated plan to deliver cost synergies and...

Icon announced a multi-year collaboration with Anthropic aimed at deploying Claude across clinical trials and trial intelligence workflows. The partnership is designed to improve site intelligence...

Tarsus Pharmaceuticals agreed to acquire Phase 3 biotech Alkeus Pharmaceuticals for $450 million upfront to expand its ophthalmology pipeline. The transaction adds near-term clinical-phase assets...

Grail is preparing for a fall FDA advisory committee meeting after reporting Q2 revenue growth of 26% and reiterating confidence in the Galleri multi-cancer early detection evidence package. Grail...