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Latest Biotech News

CRISPR-Based Tuberculosis Test Advances Community Screening in Low-Resource Settings

September 20, 2025

Researchers from Tulane University and Shenzhen Third People's Hospital have developed ActCRISPR-TB, a CRISPR-Cas12a-based tuberculosis diagnostic test optimized for non-sputum samples such as...

Dualitas Therapeutics Raises $65 Million to Advance Bispecific Drugs for Autoimmune Diseases

September 20, 2025

Dualitas Therapeutics closed a $65 million Series A funding round to develop bispecific antibodies targeting two receptors on the same immune cell for enhanced immunomodulation in autoimmune and...

FDA Approves Stealth’s Barth Syndrome Therapy: First Mitochondria-Targeted Treatment

September 20, 2025

The FDA granted approval to Stealth BioTherapeutics’ Barth syndrome therapy, marking the first mitochondria-targeted treatment for this rare genetic disorder. This regulatory milestone offers a...

AI Model Predicts Risk of Over 1,000 Diseases Up to 20 Years Ahead

September 20, 2025

A new generative artificial intelligence model, Delphi-2M, developed using UK Biobank data from over 400,000 participants, can simultaneously forecast the risk and timing of developing 1,258...

Endpoints 11 Highlights: Top Biotech Startups Driving Innovation in 2025

September 20, 2025

The Endpoints 11 list for 2025 celebrates 11 of the most promising biotech startups poised to shape the industry's future. Companies include Chai Discovery focusing on AI-driven drug design, Umoja...

CHMP Recommends, FDA Approves Subcutaneous MAbs Including Keytruda and Lunsumio

September 20, 2025

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval and the FDA has approved subcutaneous formulations of key monoclonal antibodies...

ACIP Vaccine Deliberations Stir Public Health Debate on Immunization Schedules

September 20, 2025

The U.S. CDC's Advisory Committee on Immunization Practices (ACIP) underwent contentious discussions regarding the recommendation to delay the hepatitis B birth dose in certain newborns and to...

FDA Approves Subcutaneous Keytruda Amid Competitive Immuno-Oncology Market

September 20, 2025

The U.S. Food and Drug Administration (FDA) has approved a new subcutaneous formulation of Keytruda, Merck's leading cancer immunotherapy drug. The approval seeks to provide a less invasive...

Roche Acquires 89bio to Bolster MASH Drug Portfolio with Pegozafermin

September 20, 2025

Swiss pharmaceutical giant Roche has agreed to acquire biotech firm 89bio for up to $3.5 billion, securing access to its late-stage fibroblast growth factor 21 (FGF21) analogue, pegozafermin. This...

CRISPR-Based Tuberculosis Test Offers Affordable, Non-Sputum Screening in Low-Resource Settings

September 20, 2025

Researchers led by Tulane University and Shenzhen Third People's Hospital have developed an enhanced CRISPR-based diagnostic assay, ActCRISPR-TB, designed for rapid, affordable tuberculosis (TB)...

Biotech Venture Firm T.Rx Capital Launches With $77.5 Million, Led by Robert Langer’s Son

September 20, 2025

T.Rx Capital, a newly established life sciences venture capital firm co-founded by Michael Langer, son of biotech legend Robert Langer, has closed a $77.5 million inaugural fund. The firm aims to...

AI Deep Learning Model Predicts Risk for Over 1,000 Diseases Decades in Advance

September 20, 2025

Scientists have developed a novel artificial intelligence (AI) model named Delphi-2M that simultaneously forecasts an individual's risk of developing more than 1,000 diseases with up to 20 years...

Advancements in Cell Therapy Manufacturing: Cellares Unveils Automated Quality Control Platform

September 20, 2025

Cellares announced strategic partnerships aimed at expanding capabilities of its Cell Q platform, an automated, high-throughput quality control system designed to meet commercial-scale cell...

Potential Biomarker and Therapeutic Advances in Pancreatic Cancer via HSAT Sugar Modulation

September 20, 2025

Researchers at the Salk Institute and UC San Diego have identified a cell surface sugar, antithrombin-binding heparan sulfate (HSAT), as a promising therapeutic target in pancreatic ductal...

FDA Panel Debates and Delays Critical Votes on Childhood Vaccine Recommendations

September 20, 2025

The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP), recently reconstituted under Health and Human Services Secretary Robert F. Kennedy Jr.,...

Bispecific Antibody Startup Dualitas Raises $65 Million to Advance Immune Modulation Therapies

September 20, 2025

Dualitas Therapeutics has secured $65 million in Series A funding to develop bispecific antibodies targeting two cell surface proteins on the same immune cell, leveraging proximity biology for...

Multiple Biotech IPOs Signal Renewed Investor Interest Amidst Market Uncertainty

September 20, 2025

Biopharmaceutical companies such as LB Pharmaceuticals have successfully raised significant capital via initial public offerings (IPOs) this September, with LB Pharma securing $285 million to...

Roche’s $3.5B Acquisition of 89bio Advances MASH Drug Development

September 20, 2025

Roche has agreed to acquire biotech company 89bio in a deal valued up to $3.5 billion, including upfront and contingent milestone payments. The acquisition centers on pegozafermin, an FGF21...

CDC Vaccine Advisory Panel Alters Childhood Immunization Guidelines

September 20, 2025

The U.S. CDC’s Advisory Committee on Immunization Practices (ACIP), reconstituted under Health and Human Services Secretary Robert F. Kennedy Jr., voted to revise vaccine recommendations. The...

LB Pharma Raises $285M IPO to Fund Schizophrenia Trial

September 20, 2025

New York-based biopharma LB Pharmaceuticals raised $285 million in an initial public offering to support a Phase III trial of LB-102, an oral benzamide antipsychotic candidate designed for...