Latest Biotech News

Novartis disclosed a Phase III setback for delpacibart etedesiran (del-desiran) in myotonic dystrophy type 1, failing to improve disease progression versus placebo in the HARBOR trial. The result...

Encoded Therapeutics raised $275 million in a Series F to push ETX101 into the next clinical phase for Dravet syndrome. The company’s lead program targets SCN1A-positive patients, with interim...

Teijin, Teijin Regenet, and Shinshu University Hospital agreed on a joint research program to advance manufacturing technologies for cell and gene therapies, aiming to strengthen Japan’s...

Bayer expanded access for its HER2 lung cancer therapy Hyrnuo (sevabertinib), receiving accelerated approval for first-line treatment. The FDA authorization extends use to adults with locally...

Axogen agreed to acquire Biocircuit Technologies for $200 million in cash, bringing the FDA-approved Nerve Tape sutureless nerve repair device into Axogen’s peripheral nerve portfolio. The deal is...

Echo IQ disclosed the FDA issued a not substantially equivalent determination for its AI heart failure clinical decision support software, Echosolv HF, delaying US commercialization tied to its...

Biotech’s 2026 IPOs continued to outperform through August, with 18 of 21 companies trading above their IPO prices and 13 up more than 30% as of Sept. 1. The performance comes alongside a recovery...

The FDA moved to permanent leadership for CDER and CBER, naming Michael Davis as director of CDER and Karim Mikhail as director of CBER. The continuity push included creating a new Deputy...

Kura Oncology spun out Caspian Therapeutics to develop small-molecule menin inhibitors for diabetes and other cardiometabolic diseases, starting with KO-7246. Caspian launched with $50 million in...

A new study in Cell Death & Discovery reports that fibronectin 1 can drive gastrointestinal stromal tumor (GIST) progression by promoting histone lactylation—an extracellular-matrix linked...

Novartis’ pelacarsen failed a widely watched seven-year trial aimed at lowering lipoprotein(a) and reducing heart attack or stroke risk, according to reporting summarized by STAT+. The setback...

The FDA moved to lock in stability for its top drug and biologics leadership by naming permanent directors for CDER and CBER. Michael Davis will lead CDER and Karim Mikhail will lead CBER,...

Encoded Therapeutics closed a $275 million Series F to push its Dravet gene therapy ETX101 into later-stage clinical development and expand manufacturing in-house. The company reported interim...

The FDA placed a partial clinical hold on Biohaven’s epilepsy drug opakalim shortly after the company sold rights to the therapy, according to the report. The halt affects a study analysts say may...

Bayer’s Hyrnuo (sevabertinib) received an expanded label in the U.S. to move into first-line treatment for adults with locally advanced or metastatic nonsquamous non-small-cell lung cancer...

Japan’s Teijin and Teijin Regenet teamed with Shinshu University Hospital to create a joint research agreement focused on manufacturing technologies for cell and gene therapy products, including...

Opus Genetics shared upbeat progress for its BEST1 gene therapy OPGx-BEST1, with phase I/II trial data supporting a path toward pivotal work in rare eye diseases caused by BEST1 mutations. The...

Amgen’s Imdelltra (tarlatamab) plus AstraZeneca’s Imfinzi (durvalumab) met the primary overall survival endpoint in a phase III study of first-line maintenance therapy for adults with...

Echo IQ Ltd. disclosed that the FDA issued a not substantially equivalent determination for its initial 510(k) submission for Echosolv HF, an AI-based heart failure clinical decision support...

The FDA granted Bayer label expansion for Hyrnuo (sevabertinib), shifting the company’s HER2-mutated NSCLC drug further into earlier-line care. After an accelerated approval last November for...