Get the Daily Brief
Latest Biotech News
AstraZeneca’s Gefurulimab Shows Positive Phase 3 Results in Myasthenia Gravis
AstraZeneca announced positive “high-level” results from a global Phase 3 study of gefurulimab, a once-weekly, self-administered complement C5 inhibitor, in adults with generalized myasthenia...
Malaria Transmission Halted by Single Amino Acid CRISPR Edit in Mosquitoes
A novel genetic strategy using CRISPR-Cas9 to edit a single amino acid in the mosquito FREP1 gene confers resistance to malaria parasite transmission. Rather than eliminating mosquitoes or...
Thermo Fisher Scientific Beats Earnings, Raises 2025 Guidance on Cost Cuts and Growth
Thermo Fisher Scientific reported a strong Q2 2025 performance, with revenues up 3% year-over-year to $10.86 billion, beating analyst estimates. The life sciences solutions segment grew 6%, while...
FDA Introduces National Priority Voucher Program to Accelerate Review for Onshoring and Affordability
The FDA has launched the Commissioner’s National Priority Voucher (CNPV) pilot program to grant accelerated review times of one to two months for new drugs aligning with U.S. national health...
FDA Greenlights Streamlined Stool Kit for Colorectal Cancer Screening
Geneoscopy secured FDA approval for an updated stool collection kit for its RNA-based ColoSense colorectal cancer screening test. The new streamlined kit eliminates the need for patients to...
Expanded Long-Read Sequencing Sheds New Light on Human Genome Variation
Two international research efforts, including the University of Washington-led 1KGP-LRS Consortium and collaborators from PacBio and Johns Hopkins University, have advanced long-read sequencing of...
Targeted RNA Sequencing Emerges as Effective Standalone Oncology Diagnostic
A recent Nature Medicine study from researchers at the University of Toronto and the Hospital for Sick Children demonstrated targeted RNA sequencing performs on par with DNA-based diagnostics in...
Sarepta Therapeutics Faces Clinical and Market Challenges Over Gene Therapy
Sarepta Therapeutics' gene therapy Elevidys for Duchenne muscular dystrophy is currently halted at FDA request amid safety concerns linked to patient deaths. Families and clinicians are grappling...
Abivax Ulcerative Colitis Drug Surges on Positive Phase 3 Data
French biotech Abivax saw its stock surge over 500% after reporting positive Phase 3 trial results for obefazimod, an oral miRNA-124 enhancer for moderate to severe ulcerative colitis. The pooled...
Dispatch Bio Launches with $216M to Develop Universal Solid Tumor Therapy
Dispatch Bio, backed by $216 million in funding from Arch Venture Partners, Parker Institute, and industry leaders, launched with a platform targeting a universal solid tumor treatment. Its Flare...
Thermo Fisher Raises 2025 Outlook After Strong Q2 Performance
Thermo Fisher Scientific posted a 3% year-over-year revenue increase in Q2 2025 to $10.86 billion, surpassing analyst expectations. Key segments like life sciences solutions and laboratory...
AstraZeneca Advances Treatments with Positive Trial Data and U.S. Investment
AstraZeneca reported positive Phase 3 results for gefurulimab in myasthenia gravis, achieving all primary and secondary endpoints and demonstrating meaningful clinical improvement. The company...
FDA Launches Priority Fast Track to Accelerate National Health Projects
The FDA introduced the Commissioner’s National Priority Voucher (CNPV) pilot program, offering accelerated one- to two-month reviews for projects aligned with U.S. health priorities such as...
TCG Labs Soleil Secures $400 Million to Expand Biotech Startup Portfolio in China
TCG Labs Soleil, a venture capital and biotech R&D operator, announced a $400 million funding round to accelerate the launch and development of its portfolio of single-asset biotechnology...
FDA Delays GSK’s Blenrep Decision After Advisory Committee’s Negative Vote
The FDA postponed its decision to October 23 on GSK’s Blenrep for multiple myeloma following a negative recommendation from the Oncologic Drugs Advisory Committee. The delay allows additional...
Abivax’s Ulcerative Colitis Drug Surges on Phase 3 Trial Success
French biotech Abivax's shares soared amid positive Phase 3 results for its experimental miRNA-124 enhancer, obefazimod, in treating moderately to severely active ulcerative colitis. Two pivotal...
Dispatch Bio Unveils $216 Million Solid Tumor Immunotherapy Backed by Carl June
Dispatch Bio, a new biotechnology company launched in 2022, revealed a $216 million fundraising milestone alongside its innovative two-component immunotherapy for solid tumors. The platform...
Roche Faces Hurdles as It Halts Elevidys Gene Therapy Shipments Outside US
Roche has temporarily suspended new orders of Duchenne muscular dystrophy gene therapy Elevidys in several countries that depend on FDA approval, responding to safety concerns including liver...
Arrowhead Pharmaceuticals Confirms Sarepta Deal Amid Partner’s Turmoil
Arrowhead Pharmaceuticals reassured investors it expects Sarepta Therapeutics to uphold its financial commitments under their multi-hundred-million-dollar deal involving RNA therapy programs....
FDA Launches National Priority Voucher Pilot with 2-Month Review for Onshoring, Affordability
The FDA introduced the Commissioner’s National Priority Voucher (CNPV) pilot program aimed at expediting review times to one or two months for drugs aligning with critical U.S. health priorities....