Latest Biotech News

The FDA approved Eli Lilly’s once-daily oral GLP-1 weight-loss pill Foundayo (orforglipron), setting up head-to-head commercial pressure against Novo Nordisk’s recently launched oral Wegovy pill....

Eli Lilly agreed to acquire Centessa Pharmaceuticals in a deal valued at about $6.3 billion upfront, with additional contingent value rights that could add $1.5 billion tied to approvals in...

Biogen agreed to acquire Apellis Pharmaceuticals for roughly $5.6 billion in cash, adding two commercial products and immunology nephrology expertise to its portfolio. The deal includes Apellis’...

The Trump administration has prepared an order that would impose 100% tariffs on imports of patented medications and their active ingredients, according to a STAT report citing a draft obtained in...

Gilead discontinued a Phase 2/3 trial of its long-acting oral HIV regimen after the FDA clinical hold remained in place. The program, Wonders-2, tested a combination of GS-1720 (integrase strand...

Researchers reported a manufacturing-forward approach to improve upstream stability in large-scale AAV production by reducing the volume and time sensitivity of transfection complex additions. The...

Caris Life Sciences shared finalized results for its multi-cancer early detection test Caris Detect from the Achieve I study, lifting shares on the release. The study enrolled 3,014 evaluable...

IO Biotech said it will seek bankruptcy protection after a late-stage cancer vaccine effort failed and FDA interactions tightened the path forward. The Danish developer filed an SEC notice stating...

The U.S. FDA is requesting public feedback on draft guidance for the use of digital health technologies (DHTs) in drug development. The notice involves the FDA’s CBER and CDER, aiming to clarify...

A large observational study published in JAMA examined how AI-enabled “ambient documentation” systems, or AI scribes, affected clinician workflow in routine practice. The analysis reported small...

The FDA has approved Eli Lilly’s oral GLP-1 obesity drug orforglipron for adults with obesity or overweight plus weight-related conditions, marketed as Foundayo. Approval follows Lilly’s expected...

Biogen agreed to acquire Apellis Pharmaceuticals for about $5.6 billion, extending the company’s immunology and rare-disease footprint. The deal brings two marketed therapies—Empaveli and...

Eli Lilly agreed to buy Centessa Pharmaceuticals for $6.3 billion upfront, plus additional potential value via contingent payments, securing Centessa’s orexin receptor 2 (OX2R) agonist pipeline...

FDA Commissioner Marty Makary said the agency is seeking to speed new US clinical trial processes by reducing the amount of data needed to start a trial, focusing on the portions tied to safety....

Researchers working on custom CRISPR therapies said FDA expectations for individualized genetic medicines could make scaling difficult, citing stringent manufacturing and quality control...

Caris Life Sciences reported finalized Achieve I results for its multi-cancer early detection blood test Caris Detect, updating performance metrics for sensitivity and specificity across cancer...

Geneus Technologies obtained CE marking under the EU In Vitro Diagnostic Regulation (IVDR) for its single-molecule nanopore sequencer G-seq500 and companion sequencing chip G-MK02. The...

AAV manufacturing teams are under pressure to scale while keeping vector quality consistent, particularly during the narrow transfection-complex preparation window. A reported approach describes a...

Perceptive eClinical and Kayentis announced a partnership designed to streamline clinical trial operations by integrating interactive response technology (IRT) with electronic clinical outcome...

Merck entered a discovery collaboration with Infinimmune to develop multiple therapeutic antibodies across immune-related targets. The agreement provides for up to $838 million in upfront and...